Trial Outcomes & Findings for Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections (NCT NCT02045797)
NCT ID: NCT02045797
Last Updated: 2017-11-17
Results Overview
Cure rate and withdrawal rate data points was jointly assessed in a composite endpoint for all participants who received at least one dose of GSK2140944. Cure rate was defined as the percentage of participants exhibiting clinical improvement (=\>20% reduction in overall lesion area) at the early efficacy visit. Withdrawal rate was defined as the percentage of participants who withdrew from study treatment due to a drug-related adverse event (AE) at any point while on treatment.
COMPLETED
PHASE2
126 participants
Up to Day 3
2017-11-17
Participant Flow
This study was conducted at 13 centers in the United States from 24 March 2014 to 22 July 2015.
A total of 126 participants were randomly assigned to study treatment (all randomized population). A total of 122 participants, who received study treatment, were included in the Modified Intent-to-Treat population (mITT) and safety populations. The mITT population is used in overall study numbers and demographic information.
Participant milestones
| Measure |
Gepotidacin 750 mg q12h
Participants received GSK2140944 750 milligrams (mg) intravenous (IV) every 12 hours (q12h; twice daily \[BID\]) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
Participants received GSK21409447 1000 mg IV every 8 hours (q8h) three times a day (TID) on Day 1 and Day 2 . Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
39
|
25
|
|
Overall Study
COMPLETED
|
51
|
32
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
1
|
Reasons for withdrawal
| Measure |
Gepotidacin 750 mg q12h
Participants received GSK2140944 750 milligrams (mg) intravenous (IV) every 12 hours (q12h; twice daily \[BID\]) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
Participants received GSK21409447 1000 mg IV every 8 hours (q8h) three times a day (TID) on Day 1 and Day 2 . Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
Baseline Characteristics
Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections
Baseline characteristics by cohort
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.3 Years
STANDARD_DEVIATION 11.35 • n=5 Participants
|
44.6 Years
STANDARD_DEVIATION 10.76 • n=7 Participants
|
45.8 Years
STANDARD_DEVIATION 12.64 • n=5 Participants
|
44.7 Years
STANDARD_DEVIATION 11.36 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Day 3Population: Modified Intent-to-Treat (MITT) population consisted of all randomized participants who received at least one dose of study medication.
Cure rate and withdrawal rate data points was jointly assessed in a composite endpoint for all participants who received at least one dose of GSK2140944. Cure rate was defined as the percentage of participants exhibiting clinical improvement (=\>20% reduction in overall lesion area) at the early efficacy visit. Withdrawal rate was defined as the percentage of participants who withdrew from study treatment due to a drug-related adverse event (AE) at any point while on treatment.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate
Number Cured
|
48 Participants
|
28 Participants
|
23 Participants
|
|
Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate
Number Withdrawn
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 3Population: MITT population.
The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of \>=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., \<20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Participants With Clinical Response and Outcome at Early Efficacy Visit
Clinical Success
|
48 Participants
|
28 Participants
|
23 Participants
|
|
Number of Participants With Clinical Response and Outcome at Early Efficacy Visit
Clinical Failure
|
7 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Clinical Response and Outcome at Early Efficacy Visit
Unable to Determine
|
3 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 12 to Day 18Population: MITT population.
The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of \>=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., \<20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18)
Clinical Success
|
52 Participants
|
32 Participants
|
21 Participants
|
|
Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18)
Clinical Failure
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18)
Unable to Determine
|
5 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 21 to Day 28Population: MITT population.
The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as no increase in the total surface area of the lesion (as calculated by digital imaging) compared to post therapy visit and no further administration of antibacterial therapy for the lesion under study. Clinical recurrence was defined as death of participant; increase in the area of the lesion compared to post therapy visit or administration of additional antibacterial therapy for the lesion under study before the efficacy endpoint assessment for participants who were a clinical success at post therapy visit. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28)
Clinical Success
|
50 Participants
|
28 Participants
|
20 Participants
|
|
Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28)
Clinical Failure
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28)
Clinical Recurrence
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28)
Unable to Determine
|
5 Participants
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Day 3Population: Modified Microbiological ITT consisted of all randomized participants who received at least one dose of study medication and had a Gram-positive pathogens identified from their Baseline bacteriology lesion sample.
The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=37 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=28 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=11 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample
Microbiological Success, Presumed Eradication
|
24 Number of pathogens
|
17 Number of pathogens
|
9 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample
Microbiological Success, Eradication
|
0 Number of pathogens
|
2 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample
Microbiological Failure, Persistence
|
11 Number of pathogens
|
3 Number of pathogens
|
2 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample
Microbiological Failure, Presumed Persistence
|
4 Number of pathogens
|
6 Number of pathogens
|
0 Number of pathogens
|
SECONDARY outcome
Timeframe: Day 3Population: Modified Microbiological ITT population.
The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MRSA in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=28 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=20 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=5 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample
Microbiological Success, Eradication
|
0 Number of pathogens
|
2 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample
Microbiological Success, Presumed Eradication
|
18 Number of pathogens
|
10 Number of pathogens
|
4 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample
Microbiological Failure, Persistence
|
7 Number of pathogens
|
3 Number of pathogens
|
1 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample
Microbiological Failure, Presumed Persistence
|
4 Number of pathogens
|
5 Number of pathogens
|
0 Number of pathogens
|
SECONDARY outcome
Timeframe: Up to Day 3Population: Modified Microbiological ITT population.
The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MSSA in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=10 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=8 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=6 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample
Microbiological Success, Presumed Eradication
|
6 Number of pathogens
|
7 Number of pathogens
|
5 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample
Microbiological Failure, Persistence
|
4 Number of pathogens
|
0 Number of pathogens
|
1 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample
Microbiological Failure, Presumed Persistence
|
0 Number of pathogens
|
1 Number of pathogens
|
0 Number of pathogens
|
SECONDARY outcome
Timeframe: Up to Day 3Population: Modified Microbiological ITT population.
The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for other Gram-positive aerobic pathogens in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=4 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=4 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=3 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Success, Eradication
|
2 Number of pathogens
|
2 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Success, Presumed Eradication
|
0 Number of pathogens
|
1 Number of pathogens
|
3 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Presumed Persistence
|
1 Number of pathogens
|
1 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Unable to Determine
|
1 Number of pathogens
|
0 Number of pathogens
|
0 Number of pathogens
|
SECONDARY outcome
Timeframe: Up to Day 3Population: Modified Microbiological ITT population.
The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for all Gram-positive aerobic pathogens in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=40 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=29 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=13 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Success, Eradication
|
2 Number of pathogens
|
4 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Success, Presumed Eradication
|
24 Number of pathogens
|
18 Number of pathogens
|
12 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Persistence
|
11 Number of pathogens
|
3 Number of pathogens
|
2 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Presumed Persistence
|
5 Number of pathogens
|
7 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Unable to Determine
|
1 Number of pathogens
|
0 Number of pathogens
|
0 Number of pathogens
|
SECONDARY outcome
Timeframe: Up to Day 3Population: Modified Microbiological ITT population.
The microbiological outcome was determined by comparing Baseline bacteriology blood culture, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA, MRSA and all Gram-positive aerobic pathogens in blood sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=2 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
SA, Microbiological Success, Eradication
|
2 Number of pathogens
|
—
|
—
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
MRSA, Microbiological Success, Eradication
|
2 Number of pathogens
|
—
|
—
|
|
Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
Aerobic, Microbiological Success, Eradication
|
2 Number of pathogens
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 12 to Day 18Population: Modified Microbiological ITT population.
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained at post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=37 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=28 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=11 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample
Microbiological Success, Presumed Eradication
|
32 Number of pathogens
|
24 Number of pathogens
|
8 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample
Microbiological Success, Eradication
|
3 Number of pathogens
|
1 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample
Microbiological Failure, Presumed Persistence
|
3 Number of pathogens
|
2 Number of pathogens
|
1 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample
Microbiological Failure, Presumed Recurrence
|
1 Number of pathogens
|
1 Number of pathogens
|
2 Number of pathogens
|
SECONDARY outcome
Timeframe: Day 12 to Day 18Population: Modified Microbiological ITT population.
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=28 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=20 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=5 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample
Microbiological Success, Eradication
|
3 Number of pathogens
|
0 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample
Microbiological Success, Presumed Eradication
|
22 Number of pathogens
|
17 Number of pathogens
|
4 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample
Microbiological Failure, Presumed Persistence
|
3 Number of pathogens
|
2 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample
Microbiological Failure, Presumed Recurrence
|
1 Number of pathogens
|
1 Number of pathogens
|
1 Number of pathogens
|
SECONDARY outcome
Timeframe: Day 12 to Day 18Population: Modified Microbiological ITT population.
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=10 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=8 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=6 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample
Microbiological Success, Eradication
|
0 Number of pathogens
|
1 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample
Microbiological Success, Presumed Eradication
|
10 Number of pathogens
|
7 Number of pathogens
|
4 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample
Microbiological Failure, Presumed Persistence
|
0 Number of pathogens
|
0 Number of pathogens
|
1 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample
Microbiological Failure, Presumed Recurrence
|
0 Number of pathogens
|
0 Number of pathogens
|
1 Number of pathogens
|
SECONDARY outcome
Timeframe: Day 12 to Day 18Population: Modified Microbiological ITT population.
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=4 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=4 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=3 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Success, Presumed Eradication
|
3 Number of pathogens
|
3 Number of pathogens
|
2 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Presumed Persistence
|
0 Number of pathogens
|
1 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Presumed Recurrence
|
1 Number of pathogens
|
0 Number of pathogens
|
1 Number of pathogens
|
SECONDARY outcome
Timeframe: Day 12 to Day 18Population: Modified Microbiological ITT population.
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=40 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=29 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=13 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Success, Eradication
|
3 Number of pathogens
|
1 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Success, Presumed Eradication
|
35 Number of pathogens
|
27 Number of pathogens
|
10 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Presumed Persistence
|
3 Number of pathogens
|
3 Number of pathogens
|
1 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Presumed Recurrence
|
2 Number of pathogens
|
1 Number of pathogens
|
3 Number of pathogens
|
SECONDARY outcome
Timeframe: Day 12 to Day 18Population: Modified Microbiological ITT population.
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=2 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
SA, Microbiological Success, Presumed Eradication
|
2 Number of pathogens
|
—
|
—
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
MRSA, Microbiological Success,Presumed Eradication
|
2 Number of pathogens
|
—
|
—
|
|
Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
Aerobic,MicrobiologicalSuccess,PresumedEradication
|
2 Number of pathogens
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 21 to Day 28Population: Modified Microbiological ITT.
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA pathogen in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=37 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=28 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=11 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample
Microbiological Success, Eradication
|
1 Number of pathogens
|
0 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample
Microbiological Success, Presumed Eradication
|
33 Number of pathogens
|
21 Number of pathogens
|
8 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample
Microbiological Failure, Presumed Recurrence
|
1 Number of pathogens
|
4 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample
Microbiological Failure, Unable to Determine
|
4 Number of pathogens
|
3 Number of pathogens
|
3 Number of pathogens
|
SECONDARY outcome
Timeframe: Day 21 to Day 28Population: Modified Microbiological ITT population.
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA pathogen in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=28 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=20 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=5 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample
Microbiological Success, Eradication
|
1 Number of pathogens
|
0 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample
Microbiological Success, Presumed Eradication
|
23 Number of pathogens
|
14 Number of pathogens
|
4 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample
Microbiological Failure, Presumed Recurrence
|
1 Number of pathogens
|
3 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample
Microbiological Failure, Unable to Determine
|
4 Number of pathogens
|
3 Number of pathogens
|
1 Number of pathogens
|
SECONDARY outcome
Timeframe: Day 21 to Day 28Population: Modified Microbiological ITT population.
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA pathogen in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=10 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=8 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=6 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample
Microbiological Success, Presumed Eradication
|
10 Number of pathogens
|
7 Number of pathogens
|
4 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample
Microbiological Failure, Presumed Recurrence
|
0 Number of pathogens
|
1 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample
Microbiological Failure, Unable to Determine
|
0 Number of pathogens
|
0 Number of pathogens
|
2 Number of pathogens
|
SECONDARY outcome
Timeframe: Day 21 to Day 28Population: Modified Microbiological ITT population.
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for other Gram-positive aerobic pathogens in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=4 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=4 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=3 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Success, Presumed Eradication
|
3 Number of pathogens
|
2 Number of pathogens
|
2 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Presumed Recurrence
|
0 Number of pathogens
|
1 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Unable to Determine
|
1 Number of pathogens
|
1 Number of pathogens
|
1 Number of pathogens
|
SECONDARY outcome
Timeframe: Day 21 to Day 28Population: Modified Microbiological ITT population.
Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for all Gram-positive aerobic pathogens in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=40 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=29 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=13 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Success, Eradication
|
1 Number of pathogens
|
0 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Success, Presumed Eradication
|
36 Number of pathogens
|
23 Number of pathogens
|
10 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Presumed Recurrence
|
1 Number of pathogens
|
5 Number of pathogens
|
0 Number of pathogens
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample
Microbiological Failure, Unable to Determine
|
5 Number of pathogens
|
4 Number of pathogens
|
4 Number of pathogens
|
SECONDARY outcome
Timeframe: Day 21 to Day 28Population: Modified Microbiological ITT population.
Microbiological outcome was determined by comparing Baseline blood culture, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA, MRSA and all Gram-positive aerobic pathogens in lesion sample has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=2 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
SA, Microbiological Success, Presumed Eradication
|
2 Number of pathogens
|
—
|
—
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
MRSA,Microbiological Success,Presumed Eradication
|
2 Number of pathogens
|
—
|
—
|
|
Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample
Aerobic,MicrobiologicalSuccess,PresumedEradication
|
2 Number of pathogens
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3Population: PK Parameter Population consisted of all participants in the PK concentration population for whom valid and evaluable PK parameters were derived. Only those participants available at the indicated time points were analyzed.
Samples for assessment of PK parameter Cmax was done on at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=50 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=33 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=24 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Pharmacokinetic (PK) Parameters (From GSK2140944 Plasma Concentration-time Data): Maximum Observed Concentration (Cmax) on IV Therapy
|
4590 Nanograms per milliliter
Geometric Coefficient of Variation 42.4
|
6059 Nanograms per milliliter
Geometric Coefficient of Variation 29.8
|
8848 Nanograms per milliliter
Geometric Coefficient of Variation 105.5
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)Population: PK Parameter Population. Only those participants available at the indicated time points were analyzed.
Samples for assessment of PK parameter Cmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=51 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=33 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=24 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
PK Parameters (From GSK2140944 Plasma Concentration-time Data): Cmax on Oral Dose Therapy
|
2342 Nanograms per milliliter
Geometric Coefficient of Variation 84.7
|
4329 Nanograms per milliliter
Geometric Coefficient of Variation 67.8
|
3858 Nanograms per milliliter
Geometric Coefficient of Variation 94.1
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3Population: PK Parameter Population. Only those participants available at the indicated time points were analyzed.
Samples for assessment of PK parameter tmax was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=50 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=33 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=24 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
PK Parameters (From GSK2140944 Plasma Concentration-time Data): Time to Cmax (Tmax) on IV Therapy
|
1.95 Hours
Interval 0.0 to 3.05
|
1.90 Hours
Interval 0.9 to 3.0
|
1.93 Hours
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)Population: PK Parameter Population. Only those participants available at the indicated time points were analyzed.
Samples for assessment of PK parameter tmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=51 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=33 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=24 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
PK Parameters (From GSK2140944 Plasma Concentration-time Data): Tmax on Oral Dose Therapy
|
3.00 Hours
Interval 0.95 to 12.0
|
2.92 Hours
Interval 1.02 to 12.0
|
2.98 Hours
Interval 0.98 to 8.0
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3Population: PK Parameter Population. Only those participants available at the indicated time points were analyzed.
Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on IV therapy has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=54 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=36 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=24 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy
AUClast
|
15992 Hour nanograms per milliliter
Geometric Coefficient of Variation 36.7
|
20904 Hour nanograms per milliliter
Geometric Coefficient of Variation 31.8
|
20851 Hour nanograms per milliliter
Geometric Coefficient of Variation 64.8
|
|
PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy
AUC0-tau
|
16159 Hour nanograms per milliliter
Geometric Coefficient of Variation 36.3
|
20815 Hour nanograms per milliliter
Geometric Coefficient of Variation 31.7
|
21499 Hour nanograms per milliliter
Geometric Coefficient of Variation 66.9
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)Population: PK Parameter Population. Only those participants available at the indicated time points were analyzed.
Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on oral dose therapy has been presented.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=51 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=34 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy
AUClast
|
11965 Hour nanograms per milliliter
Geometric Coefficient of Variation 101.7
|
19308 Hour nanograms per milliliter
Geometric Coefficient of Variation 98.8
|
15923 Hour nanograms per milliliter
Geometric Coefficient of Variation 117.4
|
|
PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy
AUC0-tau
|
14404 Hour nanograms per milliliter
Geometric Coefficient of Variation 78.2
|
24253 Hour nanograms per milliliter
Geometric Coefficient of Variation 65.4
|
19300 Hour nanograms per milliliter
Geometric Coefficient of Variation 77.9
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Modified MITT Population.
Reduction in susceptibility was defined as a \>=4-fold increase in minimum inhibitory concentration (MIC) or \>=6 millimeter decrease in zone size between an isolate obtained at Baseline and the same pathogen at subsequent visits.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=40 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=29 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=13 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Participants Demonstrating a Decrease in GSK2140944 Susceptibility When Comparing Isolates Recovered From Baseline With Those From Any Time Post-Baseline Skin Specimens
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Safety population comprised the same set of participants from MITT population and received at least one dose of study medication.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, medically significant or all events of possible drug-induced liver injury with hyperbilirubinemia.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
41 Participants
|
25 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
SBP and DBP was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, POST THERAPY DAY 12-18
|
-0.1 Millimeters of mercury
Standard Deviation 13.71
|
4.5 Millimeters of mercury
Standard Deviation 11.33
|
4.1 Millimeters of mercury
Standard Deviation 11.09
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ORAL - DAY 7-10
|
-1.2 Millimeters of mercury
Standard Deviation 9.12
|
0.4 Millimeters of mercury
Standard Deviation 8.13
|
0.0 Millimeters of mercury
Standard Deviation 11.13
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, POST THERAPY DAY 12-18
|
2.2 Millimeters of mercury
Standard Deviation 9.18
|
2.3 Millimeters of mercury
Standard Deviation 8.00
|
3.5 Millimeters of mercury
Standard Deviation 12.23
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, FOLLOW UP DAY 21-28
|
2.3 Millimeters of mercury
Standard Deviation 11.00
|
0.0 Millimeters of mercury
Standard Deviation 9.94
|
1.2 Millimeters of mercury
Standard Deviation 13.44
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, POST DOSE DAY 3-10
|
-5.0 Millimeters of mercury
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ON IV TREATMENT/DAY 7
|
-1.6 Millimeters of mercury
Standard Deviation 23.37
|
-13.8 Millimeters of mercury
Standard Deviation 19.09
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, FOLLOW UP DAY 21-28
|
2.5 Millimeters of mercury
Standard Deviation 12.87
|
2.1 Millimeters of mercury
Standard Deviation 12.24
|
1.7 Millimeters of mercury
Standard Deviation 15.60
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ON IV TREATMENT/DAY 1
|
-2.9 Millimeters of mercury
Standard Deviation 15.07
|
-1.7 Millimeters of mercury
Standard Deviation 13.90
|
-2.4 Millimeters of mercury
Standard Deviation 9.43
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ON IV TREATMENT/DAY 2
|
-4.8 Millimeters of mercury
Standard Deviation 14.63
|
0.3 Millimeters of mercury
Standard Deviation 13.55
|
-1.9 Millimeters of mercury
Standard Deviation 9.73
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ON IV TREATMENT/DAY 3
|
-1.7 Millimeters of mercury
Standard Deviation 14.57
|
1.6 Millimeters of mercury
Standard Deviation 11.25
|
-2.1 Millimeters of mercury
Standard Deviation 13.88
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ON IV TREATMENT/DAY 4
|
-3.2 Millimeters of mercury
Standard Deviation 14.25
|
-1.2 Millimeters of mercury
Standard Deviation 17.11
|
-22.0 Millimeters of mercury
Standard Deviation 31.11
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ON IV TREATMENT/DAY 5
|
-4.8 Millimeters of mercury
Standard Deviation 17.90
|
-1.6 Millimeters of mercury
Standard Deviation 31.01
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ON IV TREATMENT/DAY 6
|
-8.0 Millimeters of mercury
Standard Deviation 14.60
|
-2.7 Millimeters of mercury
Standard Deviation 14.83
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ON IV TREATMENT/DAY 7
|
-17.0 Millimeters of mercury
Standard Deviation 16.57
|
2.3 Millimeters of mercury
Standard Deviation 32.39
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ON IV TREATMENT/DAY 8
|
-10.3 Millimeters of mercury
Standard Deviation 29.87
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ON IV TREATMENT/DAY 9
|
12.0 Millimeters of mercury
Standard Deviation 1.41
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ON IV TREATMENT/DAY 10
|
6.0 Millimeters of mercury
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ORAL - FIRST DAY
|
1.6 Millimeters of mercury
Standard Deviation 13.36
|
2.3 Millimeters of mercury
Standard Deviation 13.86
|
-3.7 Millimeters of mercury
Standard Deviation 13.59
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, ORAL - DAY 7-10
|
2.8 Millimeters of mercury
Standard Deviation 9.14
|
1.9 Millimeters of mercury
Standard Deviation 10.55
|
-0.9 Millimeters of mercury
Standard Deviation 17.91
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, POST DOSE DAY 3-10
|
-23.0 Millimeters of mercury
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ON IV TREATMENT/DAY 1
|
-3.1 Millimeters of mercury
Standard Deviation 10.28
|
-2.9 Millimeters of mercury
Standard Deviation 10.97
|
-2.3 Millimeters of mercury
Standard Deviation 9.21
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ON IV TREATMENT/DAY 2
|
-3.5 Millimeters of mercury
Standard Deviation 10.84
|
-0.9 Millimeters of mercury
Standard Deviation 9.26
|
-2.1 Millimeters of mercury
Standard Deviation 9.77
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ON IV TREATMENT/DAY 3
|
-4.5 Millimeters of mercury
Standard Deviation 10.98
|
-0.9 Millimeters of mercury
Standard Deviation 9.93
|
-3.5 Millimeters of mercury
Standard Deviation 14.74
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ON IV TREATMENT/DAY 4
|
-1.9 Millimeters of mercury
Standard Deviation 12.19
|
0.6 Millimeters of mercury
Standard Deviation 11.19
|
-12.5 Millimeters of mercury
Standard Deviation 30.41
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ON IV TREATMENT/DAY 5
|
-0.9 Millimeters of mercury
Standard Deviation 13.66
|
-2.0 Millimeters of mercury
Standard Deviation 14.83
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ON IV TREATMENT/DAY 6
|
-1.4 Millimeters of mercury
Standard Deviation 11.75
|
-9.2 Millimeters of mercury
Standard Deviation 15.38
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ON IV TREATMENT/DAY 8
|
-0.3 Millimeters of mercury
Standard Deviation 18.50
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ON IV TREATMENT/DAY 9
|
13.0 Millimeters of mercury
Standard Deviation 21.21
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ON IV TREATMENT/DAY 10
|
8.0 Millimeters of mercury
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, ORAL - FIRST DAY
|
0.0 Millimeters of mercury
Standard Deviation 11.26
|
-1.0 Millimeters of mercury
Standard Deviation 8.44
|
-3.4 Millimeters of mercury
Standard Deviation 12.84
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Pulse rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate
ON IV TREATMENT/DAY 1
|
-4.5 Beats per minute
Standard Deviation 11.38
|
-3.8 Beats per minute
Standard Deviation 10.66
|
-2.0 Beats per minute
Standard Deviation 10.39
|
|
Change From Baseline in Pulse Rate
ON IV TREATMENT/DAY 2
|
-6.3 Beats per minute
Standard Deviation 14.31
|
-1.2 Beats per minute
Standard Deviation 10.66
|
-5.2 Beats per minute
Standard Deviation 10.78
|
|
Change From Baseline in Pulse Rate
ON IV TREATMENT/DAY 3
|
-7.5 Beats per minute
Standard Deviation 14.08
|
-6.6 Beats per minute
Standard Deviation 10.28
|
-7.1 Beats per minute
Standard Deviation 12.62
|
|
Change From Baseline in Pulse Rate
ON IV TREATMENT/DAY 4
|
-11.3 Beats per minute
Standard Deviation 18.27
|
-5.5 Beats per minute
Standard Deviation 10.37
|
-7.0 Beats per minute
Standard Deviation 12.73
|
|
Change From Baseline in Pulse Rate
ON IV TREATMENT/DAY 5
|
-15.1 Beats per minute
Standard Deviation 22.36
|
-9.9 Beats per minute
Standard Deviation 13.50
|
—
|
|
Change From Baseline in Pulse Rate
ON IV TREATMENT/DAY 6
|
-16.9 Beats per minute
Standard Deviation 21.60
|
-11.0 Beats per minute
Standard Deviation 10.22
|
—
|
|
Change From Baseline in Pulse Rate
ON IV TREATMENT/DAY 7
|
-28.4 Beats per minute
Standard Deviation 33.57
|
-18.0 Beats per minute
Standard Deviation 16.75
|
—
|
|
Change From Baseline in Pulse Rate
ON IV TREATMENT/DAY 8
|
-32.3 Beats per minute
Standard Deviation 15.63
|
—
|
—
|
|
Change From Baseline in Pulse Rate
ON IV TREATMENT/DAY 9
|
-45.5 Beats per minute
Standard Deviation 31.82
|
—
|
—
|
|
Change From Baseline in Pulse Rate
ON IV TREATMENT/DAY 10
|
-68.0 Beats per minute
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Pulse Rate
ORAL - FIRST DAY
|
-6.7 Beats per minute
Standard Deviation 15.43
|
-5.6 Beats per minute
Standard Deviation 13.47
|
-7.0 Beats per minute
Standard Deviation 11.45
|
|
Change From Baseline in Pulse Rate
ORAL - DAY 7-10
|
-1.6 Beats per minute
Standard Deviation 12.35
|
-1.8 Beats per minute
Standard Deviation 10.53
|
-5.7 Beats per minute
Standard Deviation 15.33
|
|
Change From Baseline in Pulse Rate
POST THERAPY DAY 12-18
|
-1.6 Beats per minute
Standard Deviation 15.02
|
2.7 Beats per minute
Standard Deviation 13.38
|
-7.0 Beats per minute
Standard Deviation 16.34
|
|
Change From Baseline in Pulse Rate
FOLLOW UP DAY 21-28
|
-1.6 Beats per minute
Standard Deviation 13.59
|
-1.1 Beats per minute
Standard Deviation 10.09
|
-2.5 Beats per minute
Standard Deviation 17.10
|
|
Change From Baseline in Pulse Rate
POST DOSE DAY 3-10
|
-15.0 Beats per minute
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Respiratory rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Respiratory Rate
ON IV TREATMENT/DAY 1
|
-0.4 Breaths per minute
Standard Deviation 2.66
|
-0.1 Breaths per minute
Standard Deviation 1.64
|
0.7 Breaths per minute
Standard Deviation 2.90
|
|
Change From Baseline in Respiratory Rate
ON IV TREATMENT/DAY 2
|
0.1 Breaths per minute
Standard Deviation 2.28
|
-0.3 Breaths per minute
Standard Deviation 2.37
|
-0.5 Breaths per minute
Standard Deviation 1.73
|
|
Change From Baseline in Respiratory Rate
ON IV TREATMENT/DAY 3
|
0.3 Breaths per minute
Standard Deviation 2.80
|
-0.6 Breaths per minute
Standard Deviation 1.58
|
-0.3 Breaths per minute
Standard Deviation 2.17
|
|
Change From Baseline in Respiratory Rate
ON IV TREATMENT/DAY 4
|
-0.1 Breaths per minute
Standard Deviation 1.78
|
-1.0 Breaths per minute
Standard Deviation 1.94
|
-1.0 Breaths per minute
Standard Deviation 1.41
|
|
Change From Baseline in Respiratory Rate
ON IV TREATMENT/DAY 5
|
-0.4 Breaths per minute
Standard Deviation 2.22
|
-0.7 Breaths per minute
Standard Deviation 1.25
|
—
|
|
Change From Baseline in Respiratory Rate
ON IV TREATMENT/DAY 6
|
-0.1 Breaths per minute
Standard Deviation 2.33
|
-0.8 Breaths per minute
Standard Deviation 1.47
|
—
|
|
Change From Baseline in Respiratory Rate
ON IV TREATMENT/DAY 7
|
-1.2 Breaths per minute
Standard Deviation 2.68
|
-1.0 Breaths per minute
Standard Deviation 1.15
|
—
|
|
Change From Baseline in Respiratory Rate
ON IV TREATMENT/DAY 10
|
-6.0 Breaths per minute
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Respiratory Rate
ORAL - FIRST DAY
|
0.4 Breaths per minute
Standard Deviation 2.33
|
0.3 Breaths per minute
Standard Deviation 1.66
|
0.2 Breaths per minute
Standard Deviation 1.92
|
|
Change From Baseline in Respiratory Rate
ORAL - DAY 7-10
|
-0.2 Breaths per minute
Standard Deviation 2.39
|
-0.1 Breaths per minute
Standard Deviation 2.35
|
-0.2 Breaths per minute
Standard Deviation 2.04
|
|
Change From Baseline in Respiratory Rate
POST THERAPY DAY 12-18
|
0.0 Breaths per minute
Standard Deviation 2.94
|
-0.3 Breaths per minute
Standard Deviation 1.97
|
-0.4 Breaths per minute
Standard Deviation 2.02
|
|
Change From Baseline in Respiratory Rate
FOLLOW UP DAY 21-28
|
-0.6 Breaths per minute
Standard Deviation 2.81
|
-0.3 Breaths per minute
Standard Deviation 2.04
|
-0.5 Breaths per minute
Standard Deviation 1.78
|
|
Change From Baseline in Respiratory Rate
POST DOSE DAY 3-10
|
-2.0 Breaths per minute
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Respiratory Rate
ON IV TREATMENT/DAY 8
|
-1.3 Breaths per minute
Standard Deviation 4.16
|
—
|
—
|
|
Change From Baseline in Respiratory Rate
ON IV TREATMENT/DAY 9
|
-4.0 Breaths per minute
Standard Deviation 2.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Body temperature was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign: Body Temperature
ON IV TREATMENT/DAY 1
|
-0.126 Celcius
Standard Deviation 0.6632
|
-0.053 Celcius
Standard Deviation 0.4114
|
-0.172 Celcius
Standard Deviation 0.4208
|
|
Change From Baseline in Vital Sign: Body Temperature
ON IV TREATMENT/DAY 2
|
-0.195 Celcius
Standard Deviation 0.6058
|
-0.173 Celcius
Standard Deviation 0.4642
|
-0.400 Celcius
Standard Deviation 0.5672
|
|
Change From Baseline in Vital Sign: Body Temperature
ON IV TREATMENT/DAY 3
|
-0.393 Celcius
Standard Deviation 0.5986
|
-0.308 Celcius
Standard Deviation 0.4216
|
-0.456 Celcius
Standard Deviation 0.7548
|
|
Change From Baseline in Vital Sign: Body Temperature
ON IV TREATMENT/DAY 4
|
-0.476 Celcius
Standard Deviation 0.7242
|
-0.455 Celcius
Standard Deviation 0.5610
|
-0.550 Celcius
Standard Deviation 0.2121
|
|
Change From Baseline in Vital Sign: Body Temperature
ON IV TREATMENT/DAY 5
|
-0.662 Celcius
Standard Deviation 0.8412
|
-0.521 Celcius
Standard Deviation 0.6013
|
—
|
|
Change From Baseline in Vital Sign: Body Temperature
ON IV TREATMENT/DAY 6
|
-1.080 Celcius
Standard Deviation 0.9589
|
-0.842 Celcius
Standard Deviation 1.0670
|
—
|
|
Change From Baseline in Vital Sign: Body Temperature
ON IV TREATMENT/DAY 7
|
-1.400 Celcius
Standard Deviation 1.1726
|
-0.738 Celcius
Standard Deviation 0.8901
|
—
|
|
Change From Baseline in Vital Sign: Body Temperature
ON IV TREATMENT/DAY 8
|
-0.533 Celcius
Standard Deviation 0.6110
|
—
|
—
|
|
Change From Baseline in Vital Sign: Body Temperature
ON IV TREATMENT/DAY 9
|
-0.800 Celcius
Standard Deviation 0.7071
|
—
|
—
|
|
Change From Baseline in Vital Sign: Body Temperature
ON IV TREATMENT/DAY 10
|
-1.100 Celcius
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Vital Sign: Body Temperature
ORAL - FIRST DAY
|
-0.398 Celcius
Standard Deviation 0.8149
|
-0.304 Celcius
Standard Deviation 0.7005
|
-0.608 Celcius
Standard Deviation 0.7593
|
|
Change From Baseline in Vital Sign: Body Temperature
ORAL - DAY 7-10
|
-0.498 Celcius
Standard Deviation 0.6496
|
-0.468 Celcius
Standard Deviation 0.6417
|
-0.635 Celcius
Standard Deviation 0.8483
|
|
Change From Baseline in Vital Sign: Body Temperature
POST THERAPY DAY 12-18
|
-0.485 Celcius
Standard Deviation 0.7579
|
-0.439 Celcius
Standard Deviation 0.6764
|
-0.645 Celcius
Standard Deviation 0.9379
|
|
Change From Baseline in Vital Sign: Body Temperature
FOLLOW UP DAY 21-28
|
-0.441 Celcius
Standard Deviation 0.7579
|
-0.375 Celcius
Standard Deviation 0.7255
|
-0.604 Celcius
Standard Deviation 0.8891
|
|
Change From Baseline in Vital Sign: Body Temperature
POST DOSE DAY 3-10
|
-0.200 Celcius
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Safety Population. Only those participants available at the indicated time points were analyzed.
The 12-lead ECGs was obtained at Day 1, Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for corrected QT, using Fridericia formula (QTcF), corrected QT using Bazett's formula (QTcB) and QRS intervals. The number of participants with maximum post-baseline ECG value exceeding the following limits have been reported: QTcB/QTcF interval \> 450 and ≤ 480 millisecond (msec), QTcB/QTcF interval \> 480 and ≤ 500 msec, QTcB/QTcF interval \> 500 msec, QRS interval \< 70 msec and QRS interval \> 120 msec.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=38 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings
QTcB, Maximum Post-Baseline, <=450
|
27 Participants
|
15 Participants
|
9 Participants
|
|
Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings
QTcB, Maximum Post-Baseline, <=450 and <=480
|
28 Participants
|
19 Participants
|
11 Participants
|
|
Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings
QTcB, Maximum Post-Baseline, >480 and <=500
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings
QTcB, Maximum Post-Baseline, >500
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings
QTcF, Maximum Post-Baseline, <=450
|
47 Participants
|
28 Participants
|
17 Participants
|
|
Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings
QTcF, Maximum Post-Baseline, <=450 and <=480
|
11 Participants
|
10 Participants
|
8 Participants
|
|
Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings
QRS, Maximum Post-Baseline, 70 - 120
|
56 Participants
|
36 Participants
|
23 Participants
|
|
Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings
QRS, Maximum Post-Baseline, >120
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Blood samples for assessment of clinical chemistry parameters of ALT, ALP, AST, FSH and GGT was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALT, ON IV TREATMENT/DAY 2
|
-1.9 International units per liter
Standard Deviation 5.40
|
-1.0 International units per liter
Standard Deviation 4.67
|
2.3 International units per liter
Standard Deviation 14.57
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALT, ON IV TREATMENT/DAY 3
|
1.2 International units per liter
Standard Deviation 14.63
|
1.4 International units per liter
Standard Deviation 9.71
|
1.2 International units per liter
Standard Deviation 6.30
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALT, ON IV TREATMENT/DAY 4
|
—
|
14.0 International units per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALT, ON IV TREATMENT/DAY 5
|
9.3 International units per liter
Standard Deviation 18.27
|
2.8 International units per liter
Standard Deviation 9.89
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALT, ON IV TREATMENT/DAY 7
|
37.5 International units per liter
Standard Deviation 19.09
|
18.5 International units per liter
Standard Deviation 9.19
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALT, ORAL - FIRST DAY
|
3.6 International units per liter
Standard Deviation 17.52
|
4.1 International units per liter
Standard Deviation 11.58
|
5.7 International units per liter
Standard Deviation 11.57
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALT, ORAL - DAY 7-10
|
6.6 International units per liter
Standard Deviation 15.75
|
7.3 International units per liter
Standard Deviation 17.74
|
6.3 International units per liter
Standard Deviation 12.60
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALT, POST THERAPY DAY 12-18
|
12.8 International units per liter
Standard Deviation 35.54
|
8.3 International units per liter
Standard Deviation 21.90
|
4.2 International units per liter
Standard Deviation 16.02
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALT, FOLLOW UP DAY 21-28
|
36.2 International units per liter
Standard Deviation 53.78
|
27.8 International units per liter
Standard Deviation 39.03
|
9.3 International units per liter
Standard Deviation 4.62
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALT, POST DOSE DAY 3-10
|
22.0 International units per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALP, ON IV TREATMENT/DAY 2
|
-1.4 International units per liter
Standard Deviation 11.52
|
-1.3 International units per liter
Standard Deviation 12.27
|
-4.0 International units per liter
Standard Deviation 12.23
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALP, ON IV TREATMENT/DAY 3
|
1.8 International units per liter
Standard Deviation 18.97
|
5.7 International units per liter
Standard Deviation 14.17
|
-0.4 International units per liter
Standard Deviation 6.17
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALP, ON IV TREATMENT/DAY 4
|
—
|
15.0 International units per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALP, ON IV TREATMENT/DAY 5
|
-0.3 International units per liter
Standard Deviation 13.01
|
5.0 International units per liter
Standard Deviation 11.49
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALP, ON IV TREATMENT/DAY 7
|
3.0 International units per liter
Standard Deviation 22.63
|
10.0 International units per liter
Standard Deviation 21.21
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALP, ORAL - FIRST DAY
|
5.1 International units per liter
Standard Deviation 19.30
|
4.0 International units per liter
Standard Deviation 17.38
|
-0.4 International units per liter
Standard Deviation 11.32
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALP, ORAL - DAY 7-10
|
3.8 International units per liter
Standard Deviation 13.21
|
2.2 International units per liter
Standard Deviation 19.16
|
-0.1 International units per liter
Standard Deviation 11.17
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALP, POST THERAPY DAY 12-18
|
-0.8 International units per liter
Standard Deviation 15.97
|
0.1 International units per liter
Standard Deviation 16.16
|
-1.8 International units per liter
Standard Deviation 11.72
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALP, FOLLOW UP DAY 21-28
|
4.6 International units per liter
Standard Deviation 19.49
|
15.6 International units per liter
Standard Deviation 20.84
|
-2.0 International units per liter
Standard Deviation 3.61
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
ALP, POST DOSE DAY 3-10
|
17.0 International units per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
AST, ON IV TREATMENT/DAY 2
|
-1.1 International units per liter
Standard Deviation 6.58
|
0.7 International units per liter
Standard Deviation 7.03
|
2.0 International units per liter
Standard Deviation 10.85
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
AST, ON IV TREATMENT/DAY 3
|
1.6 International units per liter
Standard Deviation 12.47
|
6.2 International units per liter
Standard Deviation 22.30
|
6.9 International units per liter
Standard Deviation 18.84
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
AST, ON IV TREATMENT/DAY 4
|
—
|
22.0 International units per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
AST, ON IV TREATMENT/DAY 5
|
7.4 International units per liter
Standard Deviation 17.95
|
4.2 International units per liter
Standard Deviation 13.01
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
AST, ON IV TREATMENT/DAY 7
|
23.0 International units per liter
Standard Deviation NA
Only one participant was analyzed.
|
22.0 International units per liter
Standard Deviation 0.00
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
AST, ORAL - FIRST DAY
|
4.3 International units per liter
Standard Deviation 13.34
|
34 International units per liter
Standard Deviation 13.52
|
6.3 International units per liter
Standard Deviation 17.83
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
AST, ORAL - DAY 7-10
|
6.7 International units per liter
Standard Deviation 12.08
|
6.8 International units per liter
Standard Deviation 13.93
|
2.3 International units per liter
Standard Deviation 17.44
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
AST, POST THERAPY DAY 12-18
|
10.9 International units per liter
Standard Deviation 18.98
|
9.0 International units per liter
Standard Deviation 15.53
|
0.8 International units per liter
Standard Deviation 19.05
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
AST, FOLLOW UP DAY 21-28
|
16.2 International units per liter
Standard Deviation 22.15
|
22.6 International units per liter
Standard Deviation 29.90
|
5.3 International units per liter
Standard Deviation 2.52
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
AST, POST DOSE DAY 3-10
|
9.0 International units per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
GGT, ON IV TREATMENT/DAY 2
|
-1.5 International units per liter
Standard Deviation 7.68
|
-1.9 International units per liter
Standard Deviation 8.10
|
-1.4 International units per liter
Standard Deviation 10.15
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
GGT, ON IV TREATMENT/DAY 3
|
1.7 International units per liter
Standard Deviation 18.66
|
3.8 International units per liter
Standard Deviation 12.23
|
1.9 International units per liter
Standard Deviation 5.16
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
GGT, ON IV TREATMENT/DAY 4
|
—
|
-4.0 International units per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
GGT, ON IV TREATMENT/DAY 5
|
3.3 International units per liter
Standard Deviation 21.70
|
-2.5 International units per liter
Standard Deviation 5.21
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
GGT, ON IV TREATMENT/DAY 7
|
25.5 International units per liter
Standard Deviation 0.71
|
-3.0 International units per liter
Standard Deviation 12.73
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
GGT, ORAL - FIRST DAY
|
3.3 International units per liter
Standard Deviation 20.16
|
4.5 International units per liter
Standard Deviation 16.25
|
-1.1 International units per liter
Standard Deviation 10.95
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
GGT, ORAL - DAY 7-10
|
3.6 International units per liter
Standard Deviation 17.06
|
7.5 International units per liter
Standard Deviation 19.89
|
-2.2 International units per liter
Standard Deviation 14.75
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
GGT, POST THERAPY DAY 12-18
|
3.0 International units per liter
Standard Deviation 15.60
|
5.3 International units per liter
Standard Deviation 21.08
|
-3.9 International units per liter
Standard Deviation 16.80
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
GGT, FOLLOW UP DAY 21-28
|
6.0 International units per liter
Standard Deviation 13.56
|
64.0 International units per liter
Standard Deviation 89.91
|
3.0 International units per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)
GGT, POST DOSE DAY 3-10
|
39.0 International units per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, ON IV TREATMENT/DAY 5
|
-0.5 Gram per liter
Standard Deviation 8.22
|
-2.3 Gram per liter
Standard Deviation 7.34
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, ON IV TREATMENT/DAY 7
|
5.5 Gram per liter
Standard Deviation 13.44
|
-1.0 Gram per liter
Standard Deviation 8.49
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, ORAL - FIRST DAY
|
1.4 Gram per liter
Standard Deviation 5.96
|
-0.2 Gram per liter
Standard Deviation 6.82
|
-1.2 Gram per liter
Standard Deviation 5.05
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, ORAL - DAY 7-10
|
3.1 Gram per liter
Standard Deviation 6.95
|
2.2 Gram per liter
Standard Deviation 5.88
|
0.5 Gram per liter
Standard Deviation 3.59
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, POST THERAPY DAY 12-18
|
2.9 Gram per liter
Standard Deviation 7.21
|
3.1 Gram per liter
Standard Deviation 9.14
|
-1.1 Gram per liter
Standard Deviation 5.93
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, FOLLOW UP DAY 21-28
|
5.0 Gram per liter
Standard Deviation 5.29
|
0.8 Gram per liter
Standard Deviation 5.06
|
-7.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, POST DOSE DAY 3-10
|
-3.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, ON IV TREATMENT/DAY 2
|
-2.4 Gram per liter
Standard Deviation 3.57
|
-1.1 Gram per liter
Standard Deviation 2.93
|
-2.9 Gram per liter
Standard Deviation 3.34
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, ON IV TREATMENT/DAY 3
|
-1.7 Gram per liter
Standard Deviation 4.09
|
-0.6 Gram per liter
Standard Deviation 3.52
|
-2.0 Gram per liter
Standard Deviation 3.46
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, ON IV TREATMENT/DAY 5
|
-1.1 Gram per liter
Standard Deviation 4.09
|
-1.5 Gram per liter
Standard Deviation 3.62
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, ON IV TREATMENT/DAY 7
|
4.0 Gram per liter
Standard Deviation 8.49
|
-0.5 Gram per liter
Standard Deviation 0.71
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, ORAL - FIRST DAY
|
0.0 Gram per liter
Standard Deviation 3.39
|
-0.2 Gram per liter
Standard Deviation 3.37
|
-0.9 Gram per liter
Standard Deviation 2.86
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, ORAL - DAY 7-10
|
1.8 Gram per liter
Standard Deviation 3.58
|
1.4 Gram per liter
Standard Deviation 3.04
|
1.2 Gram per liter
Standard Deviation 2.51
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, POST THERAPY DAY 12-18
|
2.1 Gram per liter
Standard Deviation 3.81
|
2.8 Gram per liter
Standard Deviation 4.41
|
0.8 Gram per liter
Standard Deviation 3.61
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, FOLLOW UP DAY 21-28
|
2.8 Gram per liter
Standard Deviation 2.36
|
0.3 Gram per liter
Standard Deviation 2.22
|
0.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, POST DOSE DAY 3-10
|
-4.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, ON IV TREATMENT/DAY 2
|
-3.2 Gram per liter
Standard Deviation 6.36
|
-1.9 Gram per liter
Standard Deviation 5.86
|
-5.2 Gram per liter
Standard Deviation 6.28
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, ON IV TREATMENT/DAY 3
|
-1.6 Gram per liter
Standard Deviation 7.04
|
-0.3 Gram per liter
Standard Deviation 5.88
|
-4.8 Gram per liter
Standard Deviation 6.59
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein, ON IV TREATMENT/DAY 4
|
—
|
0.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin, ON IV TREATMENT/DAY 4
|
—
|
1.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Blood samples for assessment of clinical chemistry parameters of bilirubin, creatinine, direct bilirubin and urate was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Bilirubin, ON IV TREATMENT/DAY 2
|
-1.9 Micromoles per liter
Standard Deviation 3.22
|
-1.3 Micromoles per liter
Standard Deviation 2.87
|
-2.4 Micromoles per liter
Standard Deviation 3.34
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Bilirubin, ON IV TREATMENT/DAY 3
|
-2.8 Micromoles per liter
Standard Deviation 4.42
|
-1.0 Micromoles per liter
Standard Deviation 3.61
|
-2.2 Micromoles per liter
Standard Deviation 2.73
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Bilirubin, ON IV TREATMENT/DAY 4
|
—
|
-4.0 Micromoles per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Bilirubin, ON IV TREATMENT/DAY 5
|
-2.8 Micromoles per liter
Standard Deviation 4.64
|
-4.0 Micromoles per liter
Standard Deviation 2.53
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Bilirubin, ON IV TREATMENT/DAY 7
|
0.0 Micromoles per liter
Standard Deviation 0.0
|
-4.0 Micromoles per liter
Standard Deviation 0.00
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Bilirubin, ORAL - FIRST DAY
|
-1.9 Micromoles per liter
Standard Deviation 3.87
|
-1.7 Micromoles per liter
Standard Deviation 3.12
|
-2.4 Micromoles per liter
Standard Deviation 2.69
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Bilirubin, ORAL - DAY 7-10
|
-0.9 Micromoles per liter
Standard Deviation 4.17
|
-0.7 Micromoles per liter
Standard Deviation 2.49
|
-1.7 Micromoles per liter
Standard Deviation 2.55
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Urate, ORAL - DAY 7-10
|
51.6 Micromoles per liter
Standard Deviation 55.31
|
67.0 Micromoles per liter
Standard Deviation 69.79
|
55.2 Micromoles per liter
Standard Deviation 65.32
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Bilirubin, POST THERAPY DAY 12-18
|
-1.0 Micromoles per liter
Standard Deviation 4.35
|
-0.5 Micromoles per liter
Standard Deviation 3.25
|
-1.4 Micromoles per liter
Standard Deviation 3.83
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Bilirubin, FOLLOW UP DAY 21-28
|
0.0 Micromoles per liter
Standard Deviation 8.72
|
0.0 Micromoles per liter
Standard Deviation 4.69
|
-1.3 Micromoles per liter
Standard Deviation 6.11
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Bilirubin, POST DOSE DAY 3-10
|
-2.0 Micromoles per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Creatinine, ON IV TREATMENT/DAY 2
|
3.45 Micromoles per liter
Standard Deviation 11.885
|
-2.33 Micromoles per liter
Standard Deviation 19.886
|
0.66 Micromoles per liter
Standard Deviation 8.711
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Creatinine, ON IV TREATMENT/DAY 3
|
1.30 Micromoles per liter
Standard Deviation 10.462
|
-5.35 Micromoles per liter
Standard Deviation 28.787
|
-3.93 Micromoles per liter
Standard Deviation 12.123
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Creatinine, ON IV TREATMENT/DAY 4
|
—
|
-1.70 Micromoles per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Creatinine, ON IV TREATMENT/DAY 5
|
-0.91 Micromoles per liter
Standard Deviation 10.541
|
7.37 Micromoles per liter
Standard Deviation 8.704
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Creatinine, ON IV TREATMENT/DAY 7
|
8.40 Micromoles per liter
Standard Deviation 10.607
|
6.65 Micromoles per liter
Standard Deviation 8.132
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Creatinine, ORAL - FIRST DAY
|
4.22 Micromoles per liter
Standard Deviation 11.115
|
-3.78 Micromoles per liter
Standard Deviation 27.598
|
2.37 Micromoles per liter
Standard Deviation 10.268
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Creatinine, ORAL - DAY 7-10
|
4.65 Micromoles per liter
Standard Deviation 9.930
|
0.72 Micromoles per liter
Standard Deviation 30.659
|
4.13 Micromoles per liter
Standard Deviation 9.518
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Creatinine, POST THERAPY DAY 12-18
|
3.82 Micromoles per liter
Standard Deviation 10.641
|
2.93 Micromoles per liter
Standard Deviation 26.419
|
2.08 Micromoles per liter
Standard Deviation 9.293
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Creatinine, FOLLOW UP DAY 21-28
|
9.92 Micromoles per liter
Standard Deviation 12.289
|
-1.80 Micromoles per liter
Standard Deviation 2.846
|
2.70 Micromoles per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Creatinine, POST DOSE DAY 3-10
|
-2.70 Micromoles per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Direct Bilirubin, ON IV TREATMENT/DAY 2
|
-0.3 Micromoles per liter
Standard Deviation 2.09
|
-0.6 Micromoles per liter
Standard Deviation 1.79
|
-1.1 Micromoles per liter
Standard Deviation 2.28
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Direct Bilirubin, ON IV TREATMENT/DAY 3
|
-0.2 Micromoles per liter
Standard Deviation 2.33
|
-0.7 Micromoles per liter
Standard Deviation 1.83
|
-1.3 Micromoles per liter
Standard Deviation 2.24
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Direct Bilirubin, ON IV TREATMENT/DAY 4
|
—
|
-2.0 Micromoles per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Direct Bilirubin, ON IV TREATMENT/DAY 5
|
-1.0 Micromoles per liter
Standard Deviation 1.94
|
-0.7 Micromoles per liter
Standard Deviation 2.73
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Direct Bilirubin, ON IV TREATMENT/DAY 7
|
-1.0 Micromoles per liter
Standard Deviation 1.41
|
-3.0 Micromoles per liter
Standard Deviation 1.41
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Direct Bilirubin, ORAL - FIRST DAY
|
-0.4 Micromoles per liter
Standard Deviation 2.15
|
-0.2 Micromoles per liter
Standard Deviation 2.19
|
-1.0 Micromoles per liter
Standard Deviation 2.08
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Direct Bilirubin, ORAL - DAY 7-10
|
0.0 Micromoles per liter
Standard Deviation 1.95
|
0.0 Micromoles per liter
Standard Deviation 2.10
|
-1.0 Micromoles per liter
Standard Deviation 2.16
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Direct Bilirubin, POST THERAPY DAY 12-18
|
-0.3 Micromoles per liter
Standard Deviation 2.02
|
0.0 Micromoles per liter
Standard Deviation 1.68
|
-1.2 Micromoles per liter
Standard Deviation 2.03
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Direct Bilirubin, FOLLOW UP DAY 21-28
|
1.5 Micromoles per liter
Standard Deviation 5.00
|
0.5 Micromoles per liter
Standard Deviation 1.91
|
0.0 Micromoles per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Direct Bilirubin, POST DOSE DAY 3-10
|
0.0 Micromoles per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Urate, ON IV TREATMENT/DAY 2
|
1.2 Micromoles per liter
Standard Deviation 44.16
|
-11.7 Micromoles per liter
Standard Deviation 42.46
|
-17.1 Micromoles per liter
Standard Deviation 50.43
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Urate, ON IV TREATMENT/DAY 3
|
4.2 Micromoles per liter
Standard Deviation 66.33
|
5.7 Micromoles per liter
Standard Deviation 52.02
|
-14.4 Micromoles per liter
Standard Deviation 97.10
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Urate, POST THERAPY DAY 12-18
|
60.8 Micromoles per liter
Standard Deviation 73.88
|
49.4 Micromoles per liter
Standard Deviation 83.24
|
45.3 Micromoles per liter
Standard Deviation 60.31
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Urate, ON IV TREATMENT/DAY 4
|
—
|
60.0 Micromoles per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Urate, ON IV TREATMENT/DAY 5
|
26.0 Micromoles per liter
Standard Deviation 89.47
|
46.7 Micromoles per liter
Standard Deviation 50.86
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Urate, ON IV TREATMENT/DAY 7
|
10.0 Micromoles per liter
Standard Deviation 169.71
|
90.0 Micromoles per liter
Standard Deviation 28.28
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Urate, ORAL - FIRST DAY
|
16.3 Micromoles per liter
Standard Deviation 52.46
|
2.9 Micromoles per liter
Standard Deviation 67.26
|
-1.3 Micromoles per liter
Standard Deviation 67.71
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Urate, FOLLOW UP DAY 21-28
|
7.5 Micromoles per liter
Standard Deviation 80.16
|
10.0 Micromoles per liter
Standard Deviation 102.31
|
140.0 Micromoles per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate
Urate, POST DOSE DAY 3-10
|
70.0 Micromoles per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Blood samples for assessment of clinical chemistry parameters of calcium, carbon dioxide, chloride, glucose, magnesium, potassium, sodium and urea was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Potassium, POST THERAPY DAY 12-18
|
0.28 Millimole per liter
Standard Deviation 0.543
|
0.06 Millimole per liter
Standard Deviation 0.573
|
0.22 Millimole per liter
Standard Deviation 0.487
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Glucose, ON IV TREATMENT/DAY 2
|
0.32 Millimole per liter
Standard Deviation 1.973
|
-0.31 Millimole per liter
Standard Deviation 2.863
|
-0.88 Millimole per liter
Standard Deviation 2.462
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Glucose, ON IV TREATMENT/DAY 3
|
0.40 Millimole per liter
Standard Deviation 2.144
|
0.48 Millimole per liter
Standard Deviation 3.087
|
-0.37 Millimole per liter
Standard Deviation 2.384
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Glucose, ON IV TREATMENT/DAY 4
|
—
|
6.60 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Glucose, ON IV TREATMENT/DAY 5
|
-0.51 Millimole per liter
Standard Deviation 3.257
|
1.92 Millimole per liter
Standard Deviation 1.723
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Glucose, ON IV TREATMENT/DAY 7
|
-2.65 Millimole per liter
Standard Deviation 4.313
|
3.70 Millimole per liter
Standard Deviation 2.687
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Glucose, ORAL - FIRST DAY
|
0.11 Millimole per liter
Standard Deviation 2.115
|
0.13 Millimole per liter
Standard Deviation 2.926
|
-0.04 Millimole per liter
Standard Deviation 1.619
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Glucose, ORAL - DAY 7-10
|
0.14 Millimole per liter
Standard Deviation 1.698
|
1.08 Millimole per liter
Standard Deviation 3.066
|
-0.46 Millimole per liter
Standard Deviation 1.741
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Glucose, POST THERAPY DAY 12-18
|
-0.19 Millimole per liter
Standard Deviation 1.774
|
0.34 Millimole per liter
Standard Deviation 2.719
|
-0.84 Millimole per liter
Standard Deviation 2.068
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Glucose, FOLLOW UP DAY 21-28
|
-0.38 Millimole per liter
Standard Deviation 1.284
|
1.95 Millimole per liter
Standard Deviation 3.450
|
-0.10 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Glucose, POST DOSE DAY 3-10
|
0.30 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Magnesium, ON IV TREATMENT/DAY 2
|
-0.013 Millimole per liter
Standard Deviation 0.0682
|
-0.017 Millimole per liter
Standard Deviation 0.0688
|
0.004 Millimole per liter
Standard Deviation 0.0865
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Magnesium, ON IV TREATMENT/DAY 3
|
0.007 Millimole per liter
Standard Deviation 0.0829
|
-0.012 Millimole per liter
Standard Deviation 0.0553
|
0.018 Millimole per liter
Standard Deviation 0.0689
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Magnesium, ON IV TREATMENT/DAY 4
|
—
|
0.000 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Magnesium, ON IV TREATMENT/DAY 5
|
0.044 Millimole per liter
Standard Deviation 0.0532
|
-0.040 Millimole per liter
Standard Deviation 0.0738
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Magnesium, ON IV TREATMENT/DAY 7
|
0.140 Millimole per liter
Standard Deviation 0.0000
|
-0.080 Millimole per liter
Standard Deviation 0.0283
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Magnesium, ORAL - FIRST DAY
|
-0.009 Millimole per liter
Standard Deviation 0.0709
|
-0.016 Millimole per liter
Standard Deviation 0.0592
|
0.006 Millimole per liter
Standard Deviation 0.0613
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Magnesium, ORAL - DAY 7-10
|
0.006 Millimole per liter
Standard Deviation 0.0810
|
-0.007 Millimole per liter
Standard Deviation 0.0708
|
0.021 Millimole per liter
Standard Deviation 0.0659
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Magnesium, POST THERAPY DAY 12-18
|
-0.005 Millimole per liter
Standard Deviation 0.0864
|
0.006 Millimole per liter
Standard Deviation 0.0870
|
-0.008 Millimole per liter
Standard Deviation 0.0737
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Magnesium, FOLLOW UP DAY 21-28
|
0.000 Millimole per liter
Standard Deviation 0.1347
|
-0.040 Millimole per liter
Standard Deviation 0.0283
|
0.000 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Magnesium, POST DOSE DAY 3-10
|
-0.040 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Potassium, ON IV TREATMENT/DAY 2
|
0.15 Millimole per liter
Standard Deviation 0.398
|
0.07 Millimole per liter
Standard Deviation 0.481
|
0.22 Millimole per liter
Standard Deviation 0.458
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Potassium, ON IV TREATMENT/DAY 3
|
0.24 Millimole per liter
Standard Deviation 0.353
|
0.11 Millimole per liter
Standard Deviation 0.429
|
0.16 Millimole per liter
Standard Deviation 0.433
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Potassium, ON IV TREATMENT/DAY 4
|
—
|
-0.10 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Potassium, ON IV TREATMENT/DAY 5
|
0.28 Millimole per liter
Standard Deviation 0.559
|
0.02 Millimole per liter
Standard Deviation 0.183
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Potassium, ON IV TREATMENT/DAY 7
|
—
|
0.55 Millimole per liter
Standard Deviation 0.495
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Potassium, ORAL - FIRST DAY
|
0.36 Millimole per liter
Standard Deviation 0.374
|
0.20 Millimole per liter
Standard Deviation 0.468
|
0.27 Millimole per liter
Standard Deviation 0.365
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Potassium, ORAL - DAY 7-10
|
0.29 Millimole per liter
Standard Deviation 0.483
|
0.06 Millimole per liter
Standard Deviation 0.434
|
0.05 Millimole per liter
Standard Deviation 0.533
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Potassium, FOLLOW UP DAY 21-28
|
1.03 Millimole per liter
Standard Deviation 0.877
|
-0.35 Millimole per liter
Standard Deviation 0.998
|
0.60 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Potassium, POST DOSE DAY 3-10
|
-0.10 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Sodium, ON IV TREATMENT/DAY 2
|
1.1 Millimole per liter
Standard Deviation 2.34
|
0.9 Millimole per liter
Standard Deviation 2.67
|
1.6 Millimole per liter
Standard Deviation 1.93
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Sodium, ON IV TREATMENT/DAY 3
|
1.2 Millimole per liter
Standard Deviation 2.59
|
1.0 Millimole per liter
Standard Deviation 2.65
|
1.4 Millimole per liter
Standard Deviation 4.16
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Sodium, ON IV TREATMENT/DAY 4
|
—
|
-3.0 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Sodium, ON IV TREATMENT/DAY 5
|
2.8 Millimole per liter
Standard Deviation 2.78
|
1.0 Millimole per liter
Standard Deviation 2.90
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Sodium, ON IV TREATMENT/DAY 7
|
2.0 Millimole per liter
Standard Deviation 2.83
|
0.0 Millimole per liter
Standard Deviation 8.49
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Sodium, ORAL - FIRST DAY
|
1.2 Millimole per liter
Standard Deviation 2.55
|
0.3 Millimole per liter
Standard Deviation 3.05
|
1.2 Millimole per liter
Standard Deviation 2.54
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Sodium, ORAL - DAY 7-10
|
0.8 Millimole per liter
Standard Deviation 2.44
|
0.5 Millimole per liter
Standard Deviation 2.90
|
1.3 Millimole per liter
Standard Deviation 2.55
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Sodium, POST THERAPY DAY 12-18
|
1.1 Millimole per liter
Standard Deviation 2.53
|
1.4 Millimole per liter
Standard Deviation 2.70
|
1.8 Millimole per liter
Standard Deviation 2.93
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Sodium, FOLLOW UP DAY 21-28
|
-3.0 Millimole per liter
Standard Deviation 2.71
|
-2.3 Millimole per liter
Standard Deviation 2.87
|
1.0 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Sodium, POST DOSE DAY 3-10
|
5.0 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Urea, ON IV TREATMENT/DAY 2
|
-0.11 Millimole per liter
Standard Deviation 1.308
|
-0.11 Millimole per liter
Standard Deviation 1.189
|
-0.58 Millimole per liter
Standard Deviation 1.110
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Urea, ON IV TREATMENT/DAY 3
|
-0.12 Millimole per liter
Standard Deviation 1.484
|
-0.24 Millimole per liter
Standard Deviation 1.715
|
-0.61 Millimole per liter
Standard Deviation 2.088
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Urea, ON IV TREATMENT/DAY 4
|
—
|
-1.00 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Urea, ON IV TREATMENT/DAY 5
|
-0.50 Millimole per liter
Standard Deviation 1.414
|
0.42 Millimole per liter
Standard Deviation 1.320
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Urea, ON IV TREATMENT/DAY 7
|
1.00 Millimole per liter
Standard Deviation 2.121
|
-0.25 Millimole per liter
Standard Deviation 1.061
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Urea, ORAL - FIRST DAY
|
-0.13 Millimole per liter
Standard Deviation 1.360
|
-0.56 Millimole per liter
Standard Deviation 1.650
|
-0.41 Millimole per liter
Standard Deviation 1.379
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Urea, ORAL - DAY 7-10
|
0.77 Millimole per liter
Standard Deviation 1.576
|
0.10 Millimole per liter
Standard Deviation 1.945
|
0.29 Millimole per liter
Standard Deviation 1.586
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Urea, POST THERAPY DAY 12-18
|
0.60 Millimole per liter
Standard Deviation 1.563
|
0.63 Millimole per liter
Standard Deviation 1.437
|
-0.03 Millimole per liter
Standard Deviation 1.486
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Urea, FOLLOW UP DAY 21-28
|
1.63 Millimole per liter
Standard Deviation 2.016
|
0.25 Millimole per liter
Standard Deviation 1.041
|
-1.00 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Urea, POST DOSE DAY 3-10
|
0.00 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Calcium, ON IV TREATMENT/DAY 2
|
-0.041 Millimole per liter
Standard Deviation 0.1095
|
-0.018 Millimole per liter
Standard Deviation 0.1227
|
-0.048 Millimole per liter
Standard Deviation 0.1221
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Calcium, ON IV TREATMENT/DAY 3
|
-0.007 Millimole per liter
Standard Deviation 0.1732
|
0.019 Millimole per liter
Standard Deviation 0.1247
|
-0.009 Millimole per liter
Standard Deviation 0.1289
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Calcium, ON IV TREATMENT/DAY 4
|
—
|
-0.180 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Calcium, ON IV TREATMENT/DAY 5
|
0.024 Millimole per liter
Standard Deviation 0.1313
|
-0.007 Millimole per liter
Standard Deviation 0.1440
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Calcium, ON IV TREATMENT/DAY 7
|
0.080 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
0.040 Millimole per liter
Standard Deviation 0.2263
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Calcium, ORAL - FIRST DAY
|
0.042 Millimole per liter
Standard Deviation 0.1152
|
0.022 Millimole per liter
Standard Deviation 0.1245
|
0.018 Millimole per liter
Standard Deviation 0.0908
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Calcium, ORAL - DAY 7-10
|
0.093 Millimole per liter
Standard Deviation 0.1373
|
0.064 Millimole per liter
Standard Deviation 0.1063
|
0.030 Millimole per liter
Standard Deviation 0.1231
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Calcium, POST THERAPY DAY 12-18
|
0.083 Millimole per liter
Standard Deviation 0.1440
|
0.087 Millimole per liter
Standard Deviation 0.1363
|
0.047 Millimole per liter
Standard Deviation 0.1239
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Calcium, FOLLOW UP DAY 21-28
|
0.090 Millimole per liter
Standard Deviation 0.1685
|
0.060 Millimole per liter
Standard Deviation 0.0673
|
0.060 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Calcium, POST DOSE DAY 3-10
|
-0.040 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Carbon Dioxide, ON IV TREATMENT/DAY 2
|
-0.5 Millimole per liter
Standard Deviation 2.87
|
-0.3 Millimole per liter
Standard Deviation 2.46
|
0.1 Millimole per liter
Standard Deviation 2.49
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Carbon Dioxide, ON IV TREATMENT/DAY 3
|
-0.5 Millimole per liter
Standard Deviation 3.34
|
-0.6 Millimole per liter
Standard Deviation 2.71
|
0.4 Millimole per liter
Standard Deviation 2.19
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Carbon Dioxide, ON IV TREATMENT/DAY 4
|
—
|
1.0 Millimole per liter
Standard Deviation NA
only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Carbon Dioxide, ON IV TREATMENT/DAY 5
|
0.1 Millimole per liter
Standard Deviation 4.28
|
0.7 Millimole per liter
Standard Deviation 3.39
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Carbon Dioxide, ON IV TREATMENT/DAY 7
|
6.0 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
2.5 Millimole per liter
Standard Deviation 2.12
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Carbon Dioxide, ORAL - FIRST DAY
|
-0.5 Millimole per liter
Standard Deviation 3.14
|
0.1 Millimole per liter
Standard Deviation 2.55
|
-0.4 Millimole per liter
Standard Deviation 2.97
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Carbon Dioxide, ORAL - DAY 7-10
|
-0.5 Millimole per liter
Standard Deviation 2.43
|
0.4 Millimole per liter
Standard Deviation 2.87
|
-0.2 Millimole per liter
Standard Deviation 3.09
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Carbon Dioxide, POST THERAPY DAY 12-18
|
-0.3 Millimole per liter
Standard Deviation 2.83
|
-0.1 Millimole per liter
Standard Deviation 3.32
|
1.0 Millimole per liter
Standard Deviation 1.73
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Carbon Dioxide, FOLLOW UP DAY 21-28
|
-1.5 Millimole per liter
Standard Deviation 3.32
|
2.3 Millimole per liter
Standard Deviation 1.89
|
1.0 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Carbon Dioxide, POST DOSE DAY 3-10
|
-4.0 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Chloride, ON IV TREATMENT/DAY 2
|
2.1 Millimole per liter
Standard Deviation 2.32
|
1.3 Millimole per liter
Standard Deviation 2.92
|
2.4 Millimole per liter
Standard Deviation 2.98
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Chloride, ON IV TREATMENT/DAY 3
|
2.3 Millimole per liter
Standard Deviation 2.92
|
1.4 Millimole per liter
Standard Deviation 2.78
|
2.1 Millimole per liter
Standard Deviation 4.04
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Chloride, ON IV TREATMENT/DAY 4
|
—
|
-1.0 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Chloride, ON IV TREATMENT/DAY 5
|
2.9 Millimole per liter
Standard Deviation 2.73
|
0.5 Millimole per liter
Standard Deviation 1.05
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Chloride, ON IV TREATMENT/DAY 7
|
-0.5 Millimole per liter
Standard Deviation 0.71
|
0.5 Millimole per liter
Standard Deviation 0.71
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Chloride, ORAL - FIRST DAY
|
1.4 Millimole per liter
Standard Deviation 2.52
|
0.4 Millimole per liter
Standard Deviation 2.70
|
1.1 Millimole per liter
Standard Deviation 3.13
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Chloride, ORAL - DAY 7-10
|
0.8 Millimole per liter
Standard Deviation 3.63
|
0.7 Millimole per liter
Standard Deviation 2.23
|
1.2 Millimole per liter
Standard Deviation 2.93
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Chloride, POST THERAPY DAY 12-18
|
1.7 Millimole per liter
Standard Deviation 2.75
|
1.6 Millimole per liter
Standard Deviation 3.21
|
1.8 Millimole per liter
Standard Deviation 2.95
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Chloride, FOLLOW UP DAY 21-28
|
0.5 Millimole per liter
Standard Deviation 4.93
|
-3.0 Millimole per liter
Standard Deviation 2.94
|
3.0 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
|
Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea
Chloride, POST DOSE DAY 3-10
|
4.0 Millimole per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Blood samples for assessment of clinical chemistry parameter of estimated creatinine clearance was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
POST THERAPY DAY 12-18
|
-8.8 Milliliter per minute
Standard Deviation 28.55
|
-10.4 Milliliter per minute
Standard Deviation 24.61
|
-5.6 Milliliter per minute
Standard Deviation 12.72
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
ON IV TREATMENT/DAY 2
|
-6.8 Milliliter per minute
Standard Deviation 22.65
|
-1.8 Milliliter per minute
Standard Deviation 17.47
|
-1.7 Milliliter per minute
Standard Deviation 17.98
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
ON IV TREATMENT/DAY 3
|
-4.8 Milliliter per minute
Standard Deviation 32.17
|
1.7 Milliliter per minute
Standard Deviation 30.02
|
3.8 Milliliter per minute
Standard Deviation 19.70
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
ON IV TREATMENT/DAY 4
|
—
|
5.0 Milliliter per minute
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
ON IV TREATMENT/DAY 5
|
-17.4 Milliliter per minute
Standard Deviation 59.39
|
-14.5 Milliliter per minute
Standard Deviation 14.92
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
ON IV TREATMENT/DAY 7
|
-22.0 Milliliter per minute
Standard Deviation 29.70
|
-9.5 Milliliter per minute
Standard Deviation 13.44
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
ORAL - DAY 7-10
|
-13.2 Milliliter per minute
Standard Deviation 29.04
|
-9.7 Milliliter per minute
Standard Deviation 36.67
|
-8.3 Milliliter per minute
Standard Deviation 16.53
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
ORAL - FIRST DAY
|
-12.6 Milliliter per minute
Standard Deviation 32.53
|
-1.1 Milliliter per minute
Standard Deviation 31.43
|
-6.3 Milliliter per minute
Standard Deviation 16.45
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
FOLLOW UP DAY 21-28
|
-13.7 Milliliter per minute
Standard Deviation 25.54
|
3.8 Milliliter per minute
Standard Deviation 5.74
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated
POST DOSE DAY 3-10
|
6.0 Milliliter per minute
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: Safety Population. Only those participants available at the indicated time points were analyzed.
Blood samples for assessment of clinical chemistry parameter of estradiol was collected at Baseline (Day 1). No post-baseline values were reported.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=10 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=4 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=2 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Estradiol Values at Baseline
|
229.4 Picomole per liter
Standard Deviation 196.66
|
148.8 Picomole per liter
Standard Deviation 153.58
|
23.5 Picomole per liter
Standard Deviation 23.33
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Blood samples for assessment of hematology parameters of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils, ON IV TREATMENT/DAY 2
|
0.000 Giga cells per liter
Standard Deviation 0.0330
|
0.003 Giga cells per liter
Standard Deviation 0.0220
|
0.007 Giga cells per liter
Standard Deviation 0.0216
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils, ON IV TREATMENT/DAY 3
|
-0.003 Giga cells per liter
Standard Deviation 0.0262
|
0.003 Giga cells per liter
Standard Deviation 0.0217
|
-0.014 Giga cells per liter
Standard Deviation 0.0305
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils, ON IV TREATMENT/DAY 4
|
—
|
-0.020 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils, ON IV TREATMENT/DAY 5
|
0.008 Giga cells per liter
Standard Deviation 0.0212
|
0.007 Giga cells per liter
Standard Deviation 0.0437
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils, ON IV TREATMENT/DAY 7
|
0.013 Giga cells per liter
Standard Deviation 0.0206
|
0.000 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils, ON IV TREATMENT/DAY 10
|
-0.020 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils, ORAL - FIRST DAY
|
0.000 Giga cells per liter
Standard Deviation 0.0310
|
0.000 Giga cells per liter
Standard Deviation 0.0185
|
-0.004 Giga cells per liter
Standard Deviation 0.0171
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils, ORAL - DAY 7-10
|
0.001 Giga cells per liter
Standard Deviation 0.0277
|
0.007 Giga cells per liter
Standard Deviation 0.0258
|
0.004 Giga cells per liter
Standard Deviation 0.0169
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils, POST THERAPY DAY 12-18
|
0.005 Giga cells per liter
Standard Deviation 0.0304
|
0.001 Giga cells per liter
Standard Deviation 0.0217
|
0.001 Giga cells per liter
Standard Deviation 0.0190
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils, FOLLOW UP DAY 21-28
|
0.016 Giga cells per liter
Standard Deviation 0.0114
|
-0.020 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
-0.007 Giga cells per liter
Standard Deviation 0.0404
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils, POST DOSE DAY 3-10
|
0.040 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils, ON IV TREATMENT/DAY 2
|
0.021 Giga cells per liter
Standard Deviation 0.1597
|
0.055 Giga cells per liter
Standard Deviation 0.1414
|
0.052 Giga cells per liter
Standard Deviation 0.0744
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils, ON IV TREATMENT/DAY 3
|
0.010 Giga cells per liter
Standard Deviation 0.1405
|
0.024 Giga cells per liter
Standard Deviation 0.1474
|
0.016 Giga cells per liter
Standard Deviation 0.0995
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils, ON IV TREATMENT/DAY 4
|
—
|
0.250 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils, ON IV TREATMENT/DAY 5
|
0.026 Giga cells per liter
Standard Deviation 0.0826
|
0.025 Giga cells per liter
Standard Deviation 0.1245
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils, ON IV TREATMENT/DAY 7
|
0.055 Giga cells per liter
Standard Deviation 0.1723
|
0.040 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils, ON IV TREATMENT/DAY 10
|
0.010 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils, ORAL - FIRST DAY
|
0.013 Giga cells per liter
Standard Deviation 0.1443
|
0.051 Giga cells per liter
Standard Deviation 0.2001
|
0.027 Giga cells per liter
Standard Deviation 0.0927
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils, ORAL - DAY 7-10
|
0.014 Giga cells per liter
Standard Deviation 0.1492
|
0.001 Giga cells per liter
Standard Deviation 0.1391
|
0.052 Giga cells per liter
Standard Deviation 0.1066
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils, POST THERAPY DAY 12-18
|
-0.017 Giga cells per liter
Standard Deviation 0.1168
|
0.011 Giga cells per liter
Standard Deviation 0.1320
|
0.050 Giga cells per liter
Standard Deviation 0.1298
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils, FOLLOW UP DAY 21-28
|
-0.004 Giga cells per liter
Standard Deviation 0.0716
|
0.000 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
0.060 Giga cells per liter
Standard Deviation 0.0436
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils, POST DOSE DAY 3-10
|
0.360 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes, ON IV TREATMENT/DAY 2
|
-1.39 Giga cells per liter
Standard Deviation 2.722
|
-1.35 Giga cells per liter
Standard Deviation 2.251
|
-1.47 Giga cells per liter
Standard Deviation 2.086
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes, ON IV TREATMENT/DAY 3
|
-2.04 Giga cells per liter
Standard Deviation 3.091
|
-1.80 Giga cells per liter
Standard Deviation 2.692
|
-2.94 Giga cells per liter
Standard Deviation 4.222
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes, ON IV TREATMENT/DAY 4
|
—
|
-7.10 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes, ON IV TREATMENT/DAY 5
|
-2.49 Giga cells per liter
Standard Deviation 4.376
|
-2.57 Giga cells per liter
Standard Deviation 1.402
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes, ON IV TREATMENT/DAY 7
|
-4.55 Giga cells per liter
Standard Deviation 5.108
|
-2.90 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes, ON IV TREATMENT/DAY 10
|
-11.20 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes, ORAL - FIRST DAY
|
-1.31 Giga cells per liter
Standard Deviation 2.959
|
-2.32 Giga cells per liter
Standard Deviation 2.527
|
-1.69 Giga cells per liter
Standard Deviation 2.641
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes, ORAL - DAY 7-10
|
-1.08 Giga cells per liter
Standard Deviation 2.482
|
-1.91 Giga cells per liter
Standard Deviation 2.299
|
-1.67 Giga cells per liter
Standard Deviation 2.637
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes, POST THERAPY DAY 12-18
|
-2.15 Giga cells per liter
Standard Deviation 3.053
|
-2.20 Giga cells per liter
Standard Deviation 2.464
|
-2.25 Giga cells per liter
Standard Deviation 3.152
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes, FOLLOW UP DAY 21-28
|
-2.06 Giga cells per liter
Standard Deviation 2.428
|
-5.70 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
-3.23 Giga cells per liter
Standard Deviation 5.877
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes, POST DOSE DAY 3-10
|
-12.60 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes, ON IV TREATMENT/DAY 2
|
0.019 Giga cells per liter
Standard Deviation 0.6137
|
0.009 Giga cells per liter
Standard Deviation 0.5047
|
0.358 Giga cells per liter
Standard Deviation 0.7229
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes, ON IV TREATMENT/DAY 3
|
0.263 Giga cells per liter
Standard Deviation 0.5574
|
0.094 Giga cells per liter
Standard Deviation 0.3504
|
0.129 Giga cells per liter
Standard Deviation 0.5742
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes, ON IV TREATMENT/DAY 4
|
—
|
0.790 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes, ON IV TREATMENT/DAY 5
|
0.288 Giga cells per liter
Standard Deviation 0.6918
|
0.075 Giga cells per liter
Standard Deviation 0.5417
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes, ON IV TREATMENT/DAY 7
|
0.705 Giga cells per liter
Standard Deviation 0.5291
|
0.200 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes, ON IV TREATMENT/DAY 10
|
1.230 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes, ORAL - FIRST DAY
|
0.002 Giga cells per liter
Standard Deviation 0.6844
|
-0.050 Giga cells per liter
Standard Deviation 0.7343
|
0.247 Giga cells per liter
Standard Deviation 0.8342
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes, ORAL - DAY 7-10
|
0.222 Giga cells per liter
Standard Deviation 0.6592
|
0.204 Giga cells per liter
Standard Deviation 0.7131
|
0.284 Giga cells per liter
Standard Deviation 0.6655
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes, POST-THERAPY DAY 12-18
|
0.179 Giga cells per liter
Standard Deviation 0.7122
|
0.028 Giga cells per liter
Standard Deviation 0.6588
|
0.184 Giga cells per liter
Standard Deviation 0.5295
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes, FOLLOW UP DAY 21-28
|
0.326 Giga cells per liter
Standard Deviation 0.3564
|
-0.020 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
0.097 Giga cells per liter
Standard Deviation 0.2743
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes, POST DOSE DAY 3-10
|
0.850 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes, ON IV TREATMENT/DAY 2
|
-0.054 Giga cells per liter
Standard Deviation 0.1938
|
-0.030 Giga cells per liter
Standard Deviation 0.2160
|
-0.011 Giga cells per liter
Standard Deviation 0.2524
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes, ON IV TREATMENT/DAY 3
|
-0.002 Giga cells per liter
Standard Deviation 0.2326
|
-0.133 Giga cells per liter
Standard Deviation 0.2330
|
-0.219 Giga cells per liter
Standard Deviation 0.5008
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes, ON IV TREATMENT/DAY 4
|
—
|
-0.280 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes, ON IV TREATMENT/DAY 5
|
-0.114 Giga cells per liter
Standard Deviation 0.2056
|
-0.243 Giga cells per liter
Standard Deviation 0.2448
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes, ON IV TREATMENT/DAY 7
|
0.022 Giga cells per liter
Standard Deviation 0.3231
|
-0.170 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes, ON IV TREATMENT/DAY 10
|
-0.240 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes, ORAL - FIRST DAY
|
-0.076 Giga cells per liter
Standard Deviation 0.2069
|
-0.099 Giga cells per liter
Standard Deviation 0.2379
|
-0.154 Giga cells per liter
Standard Deviation 0.2919
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes, ORAL - DAY 7-10
|
-0.014 Giga cells per liter
Standard Deviation 0.2030
|
-0.067 Giga cells per liter
Standard Deviation 0.1690
|
-0.070 Giga cells per liter
Standard Deviation 0.3348
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes, POST THERAPY DAY 12-18
|
-0.077 Giga cells per liter
Standard Deviation 0.1442
|
-0.130 Giga cells per liter
Standard Deviation 0.2240
|
-0.133 Giga cells per liter
Standard Deviation 0.3065
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes, FOLLOW UP DAY 21-28
|
0.018 Giga cells per liter
Standard Deviation 0.2969
|
0.050 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
-0.347 Giga cells per liter
Standard Deviation 0.7050
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes, POST DOSE DAY 3-10
|
0.280 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils, ON IV TREATMENT/DAY 2
|
-1.373 Giga cells per liter
Standard Deviation 2.7464
|
-1.395 Giga cells per liter
Standard Deviation 2.4280
|
-1.873 Giga cells per liter
Standard Deviation 2.0729
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils, ON IV TREATMENT/DAY 3
|
-2.324 Giga cells per liter
Standard Deviation 3.2252
|
-1.789 Giga cells per liter
Standard Deviation 2.6403
|
-2.854 Giga cells per liter
Standard Deviation 3.6332
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils, ON IV TREATMENT/DAY 4
|
—
|
-7.880 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils, ON IV TREATMENT/DAY 5
|
-2.712 Giga cells per liter
Standard Deviation 4.5024
|
-2.445 Giga cells per liter
Standard Deviation 0.9370
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils, ON IV TREATMENT/DAY 7
|
-5.403 Giga cells per liter
Standard Deviation 5.1790
|
-2.910 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils, ON IV TREATMENT/DAY 10
|
-12.250 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils, ORAL - FIRST DAY
|
-1.244 Giga cells per liter
Standard Deviation 3.0855
|
-2.229 Giga cells per liter
Standard Deviation 2.6921
|
-1.802 Giga cells per liter
Standard Deviation 2.5066
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils, ORAL - DAY 7-10
|
-1.363 Giga cells per liter
Standard Deviation 2.4532
|
-2.068 Giga cells per liter
Standard Deviation 2.3963
|
-1.930 Giga cells per liter
Standard Deviation 2.7752
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils, POST THERAPY DAY 12-18
|
-2.243 Giga cells per liter
Standard Deviation 3.2754
|
-2.111 Giga cells per liter
Standard Deviation 2.6465
|
-2.346 Giga cells per liter
Standard Deviation 3.0470
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils, FOLLOW UP DAY 21-28
|
-2.436 Giga cells per liter
Standard Deviation 2.5072
|
-5.770 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
-3.007 Giga cells per liter
Standard Deviation 5.4347
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils, POST DOSE DAY 3-10
|
-14.050 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets, ON IV TREATMENT/DAY 2
|
5.6 Giga cells per liter
Standard Deviation 37.64
|
6.3 Giga cells per liter
Standard Deviation 41.11
|
-6.7 Giga cells per liter
Standard Deviation 57.38
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets, ON IV TREATMENT/DAY 3
|
5.8 Giga cells per liter
Standard Deviation 44.94
|
3.1 Giga cells per liter
Standard Deviation 41.89
|
-0.6 Giga cells per liter
Standard Deviation 19.64
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets, ON IV TREATMENT/DAY 4
|
—
|
-30.0 Giga cells per liter
Standard Deviation NA
only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets, ON IV TREATMENT/DAY 5
|
43.7 Giga cells per liter
Standard Deviation 78.78
|
21.3 Giga cells per liter
Standard Deviation 33.02
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets, ON IV TREATMENT/DAY 7
|
77.8 Giga cells per liter
Standard Deviation 107.48
|
-9.0 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets, ON IV TREATMENT/DAY 10
|
159.0 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets, ORAL - FIRST DAY
|
44.0 Giga cells per liter
Standard Deviation 74.12
|
0.1 Giga cells per liter
Standard Deviation 73.36
|
11.6 Giga cells per liter
Standard Deviation 52.46
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets, ORAL - DAY 7-10
|
22.7 Giga cells per liter
Standard Deviation 55.11
|
33.9 Giga cells per liter
Standard Deviation 95.63
|
22.0 Giga cells per liter
Standard Deviation 63.18
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets, POST THERAPY DAY 12-18
|
17.5 Giga cells per liter
Standard Deviation 76.72
|
2.9 Giga cells per liter
Standard Deviation 88.15
|
0.6 Giga cells per liter
Standard Deviation 56.26
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets, FOLLOW UP DAY 21-28
|
21.0 Giga cells per liter
Standard Deviation 26.44
|
-92.0 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
-23.3 Giga cells per liter
Standard Deviation 62.93
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets, POST DOSE DAY 3-10
|
148.0 Giga cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Blood samples for assessment of hematology parameters of EMCHC and hemoglobin was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
EMCHC, ON IV TREATMENT/DAY 5
|
-4.3 Gram per liter
Standard Deviation 7.51
|
5.8 Gram per liter
Standard Deviation 10.85
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
EMCHC, ON IV TREATMENT/DAY 2
|
1.2 Gram per liter
Standard Deviation 6.08
|
2.0 Gram per liter
Standard Deviation 6.90
|
0.1 Gram per liter
Standard Deviation 6.94
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
EMCHC, ON IV TREATMENT/DAY 3
|
-0.4 Gram per liter
Standard Deviation 6.64
|
2.9 Gram per liter
Standard Deviation 7.67
|
2.9 Gram per liter
Standard Deviation 7.90
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
EMCHC, ON IV TREATMENT/DAY 4
|
—
|
0.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
EMCHC, ON IV TREATMENT/DAY 7
|
2.8 Gram per liter
Standard Deviation 9.60
|
6.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
EMCHC, ON IV TREATMENT/DAY 10
|
-6.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
EMCHC, ORAL - FIRST DAY
|
1.2 Gram per liter
Standard Deviation 8.08
|
0.9 Gram per liter
Standard Deviation 8.23
|
1.1 Gram per liter
Standard Deviation 6.13
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
EMCHC, ORAL - DAY 7-10
|
2.8 Gram per liter
Standard Deviation 5.55
|
2.1 Gram per liter
Standard Deviation 7.06
|
2.1 Gram per liter
Standard Deviation 8.46
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
EMCHC, POST THERAPY DAY 12-18
|
1.6 Gram per liter
Standard Deviation 6.49
|
2.1 Gram per liter
Standard Deviation 6.83
|
0.6 Gram per liter
Standard Deviation 7.93
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
EMCHC, FOLLOW UP DAY 21-28
|
5.6 Gram per liter
Standard Deviation 10.81
|
0.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
8.3 Gram per liter
Standard Deviation 13.32
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
EMCHC, POST DOSE DAY 3-10
|
21.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hemoglobin, ON IV TREATMENT/DAY 2
|
-3.0 Gram per liter
Standard Deviation 9.04
|
-1.2 Gram per liter
Standard Deviation 9.10
|
-4.0 Gram per liter
Standard Deviation 8.79
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hemoglobin, ON IV TREATMENT/DAY 3
|
-2.2 Gram per liter
Standard Deviation 10.95
|
-2.2 Gram per liter
Standard Deviation 11.13
|
-1.6 Gram per liter
Standard Deviation 8.22
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hemoglobin, ON IV TREATMENT/DAY 4
|
—
|
-8.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hemoglobin, ON IV TREATMENT/DAY 5
|
-4.7 Gram per liter
Standard Deviation 10.27
|
-8.0 Gram per liter
Standard Deviation 13.93
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hemoglobin, ON IV TREATMENT/DAY 7
|
-9.8 Gram per liter
Standard Deviation 7.80
|
3.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hemoglobin, ON IV TREATMENT/DAY 10
|
-24.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hemoglobin, ORAL - FIRST DAY
|
4.2 Gram per liter
Standard Deviation 9.42
|
-0.9 Gram per liter
Standard Deviation 12.20
|
-1.0 Gram per liter
Standard Deviation 8.20
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hemoglobin, ORAL - DAY 7-10
|
3.9 Gram per liter
Standard Deviation 11.18
|
1.8 Gram per liter
Standard Deviation 9.74
|
-0.6 Gram per liter
Standard Deviation 7.45
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hemoglobin, POST THERAPY DAY 12-18
|
3.8 Gram per liter
Standard Deviation 10.18
|
2.2 Gram per liter
Standard Deviation 9.02
|
-0.1 Gram per liter
Standard Deviation 10.85
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hemoglobin, FOLLOW UP DAY 21-28
|
8.4 Gram per liter
Standard Deviation 5.50
|
-7.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
3.0 Gram per liter
Standard Deviation 15.87
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin
Hemoglobin, POST DOSE DAY 3-10
|
-1.0 Gram per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Blood samples for assessment of hematology parameter of EMCH was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
ON IV TREATMENT/DAY 2
|
0.11 Picograms
Standard Deviation 0.413
|
0.04 Picograms
Standard Deviation 0.386
|
-0.07 Picograms
Standard Deviation 0.354
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
ON IV TREATMENT/DAY 3
|
0.00 Picograms
Standard Deviation 0.278
|
0.05 Picograms
Standard Deviation 0.495
|
-0.03 Picograms
Standard Deviation 0.374
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
ON IV TREATMENT/DAY 4
|
—
|
-0.40 Picograms
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
ON IV TREATMENT/DAY 5
|
-0.19 Picograms
Standard Deviation 0.325
|
0.12 Picograms
Standard Deviation 0.319
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
ON IV TREATMENT/DAY 7
|
0.30 Picograms
Standard Deviation 0.294
|
0.20 Picograms
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
ON IV TREATMENT/DAY 10
|
-0.20 Picograms
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
ORAL - FIRST DAY
|
0.08 Picograms
Standard Deviation 0.408
|
-0.01 Picograms
Standard Deviation 0.389
|
-0.14 Picograms
Standard Deviation 0.333
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
ORAL - DAY 7-10
|
0.01 Picograms
Standard Deviation 0.290
|
-0.03 Picograms
Standard Deviation 0.390
|
-0.06 Picograms
Standard Deviation 0.438
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
POST THERAPY DAY 12-18
|
-0.04 Picograms
Standard Deviation 0.389
|
0.01 Picograms
Standard Deviation 0.366
|
-0.08 Picograms
Standard Deviation 0.709
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
FOLLOW UP DAY 21-28
|
0.06 Picograms
Standard Deviation 0.483
|
-0.40 Picograms
Standard Deviation NA
Only one participant was analyzed.
|
1.20 Picograms
Standard Deviation 1.735
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)
POST DOSE DAY 3-10
|
0.10 Picograms
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Blood samples for assessment of hematology parameter of EMCV was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
POST THERAPY DAY 12-18
|
-0.6 Femtoliter
Standard Deviation 1.76
|
-0.5 Femtoliter
Standard Deviation 1.59
|
-0.5 Femtoliter
Standard Deviation 1.68
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
FOLLOW UP DAY 21-28
|
-1.6 Femtoliter
Standard Deviation 1.82
|
-2.0 Femtoliter
Standard Deviation NA
Only one participant was analyzed.
|
2.3 Femtoliter
Standard Deviation 3.21
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
ORAL - DAY 7-10
|
-0.8 Femtoliter
Standard Deviation 1.52
|
-0.6 Femtoliter
Standard Deviation 1.50
|
-0.9 Femtoliter
Standard Deviation 1.77
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
ON IV TREATMENT/DAY 2
|
0.0 Femtoliter
Standard Deviation 1.73
|
-0.4 Femtoliter
Standard Deviation 1.56
|
-0.1 Femtoliter
Standard Deviation 1.90
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
ON IV TREATMENT/DAY 3
|
0.0 Femtoliter
Standard Deviation 1.61
|
-0.6 Femtoliter
Standard Deviation 1.63
|
-0.9 Femtoliter
Standard Deviation 1.96
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
ON IV TREATMENT/DAY 4
|
—
|
-2.0 Femtoliter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
ON IV TREATMENT/DAY 5
|
0.7 Femtoliter
Standard Deviation 2.06
|
-1.0 Femtoliter
Standard Deviation 2.68
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
ON IV TREATMENT/DAY 7
|
0.0 Femtoliter
Standard Deviation 3.65
|
-1.0 Femtoliter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
ON IV TREATMENT/DAY 10
|
1.0 Femtoliter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
ORAL - FIRST DAY
|
0.0 Femtoliter
Standard Deviation 1.96
|
-0.3 Femtoliter
Standard Deviation 2.11
|
-0.7 Femtoliter
Standard Deviation 1.66
|
|
Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)
POST DOSE DAY 3-10
|
-7.0 Femtoliter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Blood samples for assessment of hematology parameter of erythrocyte was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Erythrocytes
ON IV TREATMENT/DAY 2
|
-0.14 Trillion cells per liter
Standard Deviation 0.332
|
-0.04 Trillion cells per liter
Standard Deviation 0.340
|
-0.12 Trillion cells per liter
Standard Deviation 0.345
|
|
Change From Baseline in Hematology Parameters: Erythrocytes
ON IV TREATMENT/DAY 3
|
-0.09 Trillion cells per liter
Standard Deviation 0.430
|
-0.06 Trillion cells per liter
Standard Deviation 0.430
|
-0.07 Trillion cells per liter
Standard Deviation 0.320
|
|
Change From Baseline in Hematology Parameters: Erythrocytes
ON IV TREATMENT/DAY 4
|
—
|
-0.30 Trillion cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocytes
ON IV TREATMENT/DAY 5
|
-0.14 Trillion cells per liter
Standard Deviation 0.373
|
-0.28 Trillion cells per liter
Standard Deviation 0.475
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocytes
ON IV TREATMENT/DAY 7
|
-0.35 Trillion cells per liter
Standard Deviation 0.238
|
0.10 Trillion cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocytes
ON IV TREATMENT/DAY 10
|
-0.80 Trillion cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Erythrocytes
ORAL - FIRST DAY
|
0.12 Trillion cells per liter
Standard Deviation 0.362
|
-0.01 Trillion cells per liter
Standard Deviation 0.420
|
-0.01 Trillion cells per liter
Standard Deviation 0.317
|
|
Change From Baseline in Hematology Parameters: Erythrocytes
ORAL - DAY 7-10
|
0.12 Trillion cells per liter
Standard Deviation 0.400
|
0.07 Trillion cells per liter
Standard Deviation 0.383
|
-0.01 Trillion cells per liter
Standard Deviation 0.284
|
|
Change From Baseline in Hematology Parameters: Erythrocytes
POST THERAPY DAY 12-18
|
0.13 Trillion cells per liter
Standard Deviation 0.360
|
0.07 Trillion cells per liter
Standard Deviation 0.346
|
0.02 Trillion cells per liter
Standard Deviation 0.416
|
|
Change From Baseline in Hematology Parameters: Erythrocytes
FOLLOW UP DAY 21-28
|
0.26 Trillion cells per liter
Standard Deviation 0.182
|
-0.20 Trillion cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
-0.03 Trillion cells per liter
Standard Deviation 0.351
|
|
Change From Baseline in Hematology Parameters: Erythrocytes
POST DOSE DAY 3-10
|
0.00 Trillion cells per liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 28Population: Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Blood samples for assessment of hematology parameter of hematocrit was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Hematocrit
ON IV TREATMENT/DAY 2
|
-0.0111 Ratio
Standard Deviation 0.03004
|
-0.0065 Ratio
Standard Deviation 0.03316
|
-0.0125 Ratio
Standard Deviation 0.03152
|
|
Change From Baseline in Hematology Parameters: Hematocrit
ON IV TREATMENT/DAY 3
|
-0.0066 Ratio
Standard Deviation 0.03683
|
-0.0099 Ratio
Standard Deviation 0.03922
|
-0.0073 Ratio
Standard Deviation 0.02536
|
|
Change From Baseline in Hematology Parameters: Hematocrit
ON IV TREATMENT/DAY 4
|
—
|
-0.0260 Ratio
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Hematocrit
ON IV TREATMENT/DAY 5
|
-0.0101 Ratio
Standard Deviation 0.03166
|
-0.0322 Ratio
Standard Deviation 0.04462
|
—
|
|
Change From Baseline in Hematology Parameters: Hematocrit
ON IV TREATMENT/DAY 7
|
-0.0353 Ratio
Standard Deviation 0.01873
|
0.0020 Ratio
Standard Deviation NA
Only one participant was analyzed.
|
—
|
|
Change From Baseline in Hematology Parameters: Hematocrit
ON IV TREATMENT/DAY 10
|
-0.0690 Ratio
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Hematology Parameters: Hematocrit
ORAL - FIRST DAY
|
0.0112 Ratio
Standard Deviation 0.03422
|
-0.0041 Ratio
Standard Deviation 0.04091
|
-0.0043 Ratio
Standard Deviation 0.02854
|
|
Change From Baseline in Hematology Parameters: Hematocrit
ORAL - DAY 7-10
|
0.0080 Ratio
Standard Deviation 0.03674
|
0.0027 Ratio
Standard Deviation 0.03459
|
-0.0040 Ratio
Standard Deviation 0.02840
|
|
Change From Baseline in Hematology Parameters: Hematocrit
POST THERAPY DAY 12-18
|
0.0100 Ratio
Standard Deviation 0.03340
|
0.0039 Ratio
Standard Deviation 0.02846
|
-0.0006 Ratio
Standard Deviation 0.04085
|
|
Change From Baseline in Hematology Parameters: Hematocrit
FOLLOW UP DAY 21-28
|
0.0178 Ratio
Standard Deviation 0.01699
|
-0.0220 Ratio
Standard Deviation NA
Only one participant was analyzed.
|
0.0033 Ratio
Standard Deviation 0.03988
|
|
Change From Baseline in Hematology Parameters: Hematocrit
POST DOSE DAY 3-10
|
-0.0320 Ratio
Standard Deviation NA
Only one participant was analyzed.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 28Population: Safety Population. Only those participants available at the indicated time points were analyzed.
Samples for urinalysis assessment was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for Glucose, Ketones, Occult Blood, Protein and pH. Participants with abnormal urinalysis result was reported.
Outcome measures
| Measure |
Gepotidacin 750 mg q12h
n=58 Participants
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 Participants
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 Participants
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
pH, Post-Baseline Maximum, 8.5
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, BASELINE/DAY 1, Trace
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, BASELINE/DAY 1, 1+
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, BASELINE/DAY 1, 3+
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ON IV TREATMENT/DAY 2, Trace
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ON IV TREATMENT/DAY 2, 1+
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ON IV TREATMENT/DAY 2, 3+
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ON IV TREATMENT/DAY 3, 2+
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ON IV TREATMENT/DAY 3, 3+
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ON IV TREATMENT/DAY 5, 2+
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ON IV TREATMENT/DAY 7, 2+
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ORAL - FIRST DAY, Trace
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ORAL - FIRST DAY, 1+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ORAL - FIRST DAY, 3+
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ORAL - DAY 7-10, Trace
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ORAL - DAY 7-10, 1+
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ORAL - DAY 7-10, 2+
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, ORAL - DAY 7-10, 3+
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, POST THERAPY DAY 12-18, Trace
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, POST THERAPY DAY 12-18, 1+
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Glucose, POST THERAPY DAY 12-18, 3+
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Ketones, BASELINE/DAY 1, Trace
|
8 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Ketones, BASELINE/DAY 1, 1+
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Ketones, BASELINE/DAY 1, 3+
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Ketones, ON IV TREATMENT/DAY 2, Trace
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Ketones, ON IV TREATMENT/DAY 2, 1+
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Ketones, ON IV TREATMENT/DAY 2, 3+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Ketones, ON IV TREATMENT/DAY 3, Trace
|
5 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Ketones, ORAL - FIRST DAY, Trace
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Ketones, ORAL - FIRST DAY, 2+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Ketones, ORAL - DAY 7-10, Trace
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Ketones, POST THERAPY DAY 12-18, Trace
|
8 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, BASELINE/DAY 1, Trace
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, BASELINE/DAY 1, 1+
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, BASELINE/DAY 1, 2+
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, BASELINE/DAY 1, 3+
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ON IV TREATMENT/DAY 2, Trace
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ON IV TREATMENT/DAY 2, 1+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ON IV TREATMENT/DAY 2, 2+
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ON IV TREATMENT/DAY 2, 3+
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ON IV TREATMENT/DAY 3, Trace
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ON IV TREATMENT/DAY 3, 3+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ON IV TREATMENT/DAY 5, Trace
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ON IV TREATMENT/DAY 7, Trace
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ORAL - FIRST DAY, Trace
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ORAL - FIRST DAY, 1+
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ORAL - FIRST DAY, 2+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ORAL - FIRST DAY, 3+
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ORAL - DAY 7-10, Trace
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ORAL - DAY 7-10, 2+
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, ORAL - DAY 7-10, 3+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, POST THERAPY DAY 12-18, Trace
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, POST THERAPY DAY 12-18, 1+
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, POST THERAPY DAY 12-18, 2+
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Occult Blood, POST THERAPY DAY 12-18, 3+
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, BASELINE/DAY 1, Trace
|
7 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, BASELINE/DAY 1, 1+
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, BASELINE/DAY 1, 2+
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, BASELINE/DAY 1, 3+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ON IV TREATMENT/DAY 2, Trace
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ON IV TREATMENT/DAY 2, 1+
|
7 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ON IV TREATMENT/DAY 3, Trace
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ON IV TREATMENT/DAY 3, 1+
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ON IV TREATMENT/DAY 3, 2+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ON IV TREATMENT/DAY 5, Trace
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ON IV TREATMENT/DAY 5, 1+
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ORAL - FIRST DAY, Trace
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ORAL - FIRST DAY, 1+
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ORAL - FIRST DAY, 2+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ORAL - DAY 7-10, Trace
|
7 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ORAL - DAY 7-10, 1+
|
6 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, ORAL - DAY 7-10, 2+
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, POST THERAPY DAY 12-18, Trace
|
8 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, POST THERAPY DAY 12-18, 1+
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
Protein, POST THERAPY DAY 12-18, 2+
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Gepotidacin 750 mg q12h
Gepotidacin 1000 mg q12h
Gepotidacin 1000 mg q8h
Serious adverse events
| Measure |
Gepotidacin 750 mg q12h
n=58 participants at risk
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 participants at risk
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 participants at risk
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
1.7%
1/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
0.00%
0/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
0.00%
0/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
|
Infections and infestations
Septic shock
|
0.00%
0/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
2.6%
1/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
0.00%
0/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
Other adverse events
| Measure |
Gepotidacin 750 mg q12h
n=58 participants at risk
Participants received GSK2140944 750 mg IV every 12 hours (q12h; BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 1500 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 750 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q12h
n=39 participants at risk
Participants received GSK2140944 1000 mg IV q12h (BID) on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h (BID) at investigator's discretion or continued to receive GSK2140944 1000 mg IV q12h (BID) from Day 3 to Day 10.
|
Gepotidacin 1000 mg q8h
n=25 participants at risk
Participants received GSK21409447 1000 mg IV q8h TID on Day 1 and Day 2. Participants switched to oral GSK2140944 2000 mg q12h TID at investigator's discretion or continued to receive GSK2140944 1000 mg IV q8h TID from Day 3 to Day 10.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
20.7%
12/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
23.1%
9/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
16.0%
4/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
5/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
15.4%
6/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
20.0%
5/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
3/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
5.1%
2/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
12.0%
3/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
|
Gastrointestinal disorders
Flatulence
|
5.2%
3/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
2.6%
1/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
8.0%
2/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
0.00%
0/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
8.0%
2/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
|
Investigations
Alanine aminotransferase increased
|
6.9%
4/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
7.7%
3/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
8.0%
2/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
|
Investigations
Aspartate aminotransferase increased
|
5.2%
3/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
7.7%
3/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
4.0%
1/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.2%
3/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
7.7%
3/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
0.00%
0/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
|
Nervous system disorders
Headache
|
10.3%
6/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
2.6%
1/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
0.00%
0/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
|
General disorders
Infusion site extravasation
|
5.2%
3/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
2.6%
1/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
0.00%
0/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.7%
1/58 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
7.7%
3/39 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
0.00%
0/25 • AEs were collected up to follow-up (Day 28).
Safety population was used.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER