Trial Outcomes & Findings for Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI) (NCT NCT04187144)
NCT ID: NCT04187144
Last Updated: 2023-07-18
Results Overview
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at Baseline \[BL\] to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1606 participants
Primary outcome timeframe
TOC visit (Days 9 to 16)
Results posted on
2023-07-18
Participant Flow
1605 unique participants were enrolled in the study including one participant that was randomized twice in error. This participant signed two different informed consent forms, therefore that participant was counted as enrolling twice.
Participant milestones
| Measure |
Gepotidacin
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Overall Study
STARTED
|
805
|
800
|
|
Overall Study
Safety Population
|
804
|
798
|
|
Overall Study
Microbiological ITT (Micro ITT) Population
|
331
|
324
|
|
Overall Study
Micro-ITT NTF-S Population
|
292
|
275
|
|
Overall Study
Micro-ITT NTF-S (IA Set) Population
|
277
|
264
|
|
Overall Study
COMPLETED
|
748
|
759
|
|
Overall Study
NOT COMPLETED
|
57
|
41
|
Reasons for withdrawal
| Measure |
Gepotidacin
Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
11
|
|
Overall Study
Withdrawal by Subject
|
20
|
18
|
|
Overall Study
Adverse Event
|
19
|
4
|
|
Overall Study
Physician Decision
|
5
|
3
|
|
Overall Study
Screening Failure due to creatinine clearance and body mass index
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
1
|
4
|
Baseline Characteristics
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
Baseline characteristics by cohort
| Measure |
Gepotidacin
n=805 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=800 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Total
n=1605 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.2 Years
STANDARD_DEVIATION 17.84 • n=5 Participants
|
48.4 Years
STANDARD_DEVIATION 17.72 • n=7 Participants
|
48.3 Years
STANDARD_DEVIATION 17.77 • n=5 Participants
|
|
Age, Customized
Less than (<) 18 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Customized
More than or equal to (>=) 18 years to 50 years
|
427 Participants
n=5 Participants
|
430 Participants
n=7 Participants
|
857 Participants
n=5 Participants
|
|
Age, Customized
More than (>) 50 years
|
370 Participants
n=5 Participants
|
367 Participants
n=7 Participants
|
737 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
805 Participants
n=5 Participants
|
800 Participants
n=7 Participants
|
1605 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
246 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
559 Participants
n=5 Participants
|
568 Participants
n=7 Participants
|
1127 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
51 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
74 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
674 Participants
n=5 Participants
|
668 Participants
n=7 Participants
|
1342 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Baseline Acute Cystitis Recurrence
Recurrent Infection
|
334 Participants
n=5 Participants
|
338 Participants
n=7 Participants
|
672 Participants
n=5 Participants
|
|
Baseline Acute Cystitis Recurrence
Non-Recurrent Infection
|
471 Participants
n=5 Participants
|
462 Participants
n=7 Participants
|
933 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Microbiological intent-to-treat susceptible to nitrofurantoin - (Micro-ITT NTF-S) (Interim Analysis \[IA\] Set) population included participants in the micro ITT NTF-S who per the interim analysis data had the opportunity to reach their Test of Cure (TOC) visit, or had not yet reached their TOC visit, but were already known to be failures.
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at Baseline \[BL\] to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Outcome measures
| Measure |
Gepotidacin
n=277 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=264 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set)
Therapeutic Success
|
162 Participants
|
115 Participants
|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set)
Therapeutic Failure
|
115 Participants
|
149 Participants
|
PRIMARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Micro-ITT NTF-S population
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at Baseline \[BL\] to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Outcome measures
| Measure |
Gepotidacin
n=292 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=275 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population
Therapeutic Success
|
172 Participants
|
121 Participants
|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population
Therapeutic Failure
|
120 Participants
|
154 Participants
|
SECONDARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Micro-ITT NTF-S population
Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at baseline (BL) (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
Outcome measures
| Measure |
Gepotidacin
n=292 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=275 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Clinical Improvement (CI)
|
51 Participants
|
68 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Clinical Resolution
|
199 Participants
|
175 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Clinical Worsening (CW)
|
20 Participants
|
17 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Unable to Determine
|
22 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Micro-ITT NTF-S population.
Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.
Outcome measures
| Measure |
Gepotidacin
n=292 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=275 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population
Clinical Success
|
199 Participants
|
175 Participants
|
|
Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population
Clinical Failure
|
93 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: TOC Visit (Days 9 to 16)Population: Micro-ITT NTF-S population.
Participant-level MOs at TOC were categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.
Outcome measures
| Measure |
Gepotidacin
n=292 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=275 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population
Microbiological Eradication (ME)
|
213 Participants
|
158 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population
Microbiological Persistence (MP)
|
13 Participants
|
31 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population
Microbiological Recurrence (MR)
|
19 Participants
|
52 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population
Unable to Determine (UTD)
|
47 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Micro-ITT NTF-S population.
Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP)s had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.
Outcome measures
| Measure |
Gepotidacin
n=292 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=275 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population
Microbiological Success
|
213 Participants
|
158 Participants
|
|
Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population
Microbiological Failure
|
79 Participants
|
117 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Micro-ITT NTF-S population.
TR at FU was categorized as therapeutic success and therapeutic failure. A therapeutic success at FU referred to participants who have been deemed both a microbiological success (reduction of all QUPs recovered at BL to \<10\^3 CFU/mL, following microbiological eradication at the TOC visit, without receiving other AB before the FU visit) and a clinical success (resolution of signs and symptoms of acute cystitis demonstrated at the TOC visit persist at the FU visit and no new signs and symptoms, without receiving other AB before the FU visit \[or AB for uUTI on day of FU visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Outcome measures
| Measure |
Gepotidacin
n=292 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=275 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Therapeutic Success
|
126 Participants
|
95 Participants
|
|
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Therapeutic Failure
|
166 Participants
|
180 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Micro-ITT NTF-S population
Clinical outcomes at FU were categorized as SCR, DCR, CI, CW, CR and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at the TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. Unable to determine outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for the current infection (uUTI) prior to the assessment (unless CS or CR outcome criteria were met).
Outcome measures
| Measure |
Gepotidacin
n=292 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=275 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Sustained Clinical Resolution (SCR)
|
168 Participants
|
154 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Delayed Clinical Resolution (DCR)
|
34 Participants
|
35 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical Improvement (CI)
|
15 Participants
|
19 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical Worsening (CW)
|
26 Participants
|
32 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical Recurrence (CR)
|
8 Participants
|
7 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Unable to Determine (UTD)
|
41 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Micro-ITT NTF-S population
Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
Outcome measures
| Measure |
Gepotidacin
n=292 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=275 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical Success
|
168 Participants
|
154 Participants
|
|
Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical Failure
|
124 Participants
|
121 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Micro-ITT NTF-S population.
Participant-level MOs at FU were categorized as sustained microbiological eradication (SME), microbiological recurrence (MR), microbiological persistence (MP), delayed microbiological eradication (DME) and unable to determine (UTD). SME at FU was defined as all baseline QUPs had an outcome of sustained eradication at FU (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the FU Visit). MR at FU was defined as at least one QUP had an outcome of recurrence (≥10\^3 CFU/mL) and none had an outcome of persistence at FU. MP at FU was defined as at least one QUP had an outcome of persistence at FU. DME at FU was defined as at least one QUP had an outcome of delayed eradication and none had an outcome of persistence or recurrence at FU. UTD at FU was defined as all QUP outcomes were unable to determine at FU.
Outcome measures
| Measure |
Gepotidacin
n=292 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=275 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Sustained Microbiological Eradication (SME)
|
154 Participants
|
119 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Microbiological Persistence (MP)
|
19 Participants
|
44 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Microbiological Recurrence (MR)
|
29 Participants
|
23 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Delayed Microbiological Eradication (DME)
|
20 Participants
|
28 Participants
|
|
Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Unable to Determine (UTD)
|
70 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Micro-ITT NTF-S population.
Participant- level microbiological response at FU was categorized as microbiological success and microbiological failure. Microbiological success at FU was defined as all baseline QUPs had a microbiological outcome of sustained eradication at FU visit. Microbiological failure at FU was defined as not meeting criteria of microbiological success including those participants with UTD outcome.
Outcome measures
| Measure |
Gepotidacin
n=292 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=275 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Microbiological Success
|
154 Participants
|
119 Participants
|
|
Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Microbiological Failure
|
138 Participants
|
156 Participants
|
SECONDARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Intent-to-Treat (ITT) population included all participants randomly assigned to study treatment.
Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution symptoms of acute cystitis present at baseline (BL) (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
Outcome measures
| Measure |
Gepotidacin
n=805 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=800 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical Resolution
|
549 Participants
|
517 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical Improvement
|
153 Participants
|
199 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical Worsening
|
36 Participants
|
39 Participants
|
|
Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population
Unable to Determine
|
67 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: TOC visit (Days 9 to 16)Population: Intent-to-Treat (ITT) population
Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure.
Outcome measures
| Measure |
Gepotidacin
n=805 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=800 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical Success
|
549 Participants
|
517 Participants
|
|
Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical Failure
|
256 Participants
|
283 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Intent-to-Treat (ITT) population
Clinical outcomes at FU were categorized as Sustained Clinical Response (SCR), Delayed Clinical Response (DCR), CI, CW, Clinical Recurrence (CR) and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. UTD outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for current infection (uUTI) prior to assessment (unless CS or CR outcome criteria were met).
Outcome measures
| Measure |
Gepotidacin
n=805 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=800 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Sustained Clinical Resolution (SCR)
|
478 Participants
|
443 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Delayed Clinical Resolution (DCR)
|
108 Participants
|
116 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical Improvement (CI)
|
40 Participants
|
52 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical Worsening (CW)
|
51 Participants
|
65 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical Recurrence (CR)
|
25 Participants
|
28 Participants
|
|
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Unable to Determine (UTD)
|
103 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: FU visit (Days 21 to 31)Population: Intent-to-Treat (ITT) population
Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
Outcome measures
| Measure |
Gepotidacin
n=805 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=800 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical Success
|
478 Participants
|
443 Participants
|
|
Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical Failure
|
327 Participants
|
357 Participants
|
SECONDARY outcome
Timeframe: From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)Population: Safety population included all randomized participants who receive at least 1 dose of study treatment.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. 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 study treatment.
Outcome measures
| Measure |
Gepotidacin
n=804 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=798 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
285 Participants
|
200 Participants
|
SECONDARY outcome
Timeframe: From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)Population: Safety population included all randomized participants who receive at least 1 dose of study treatment.
An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.
Outcome measures
| Measure |
Gepotidacin
n=804 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=798 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of hematology parameters: neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=736 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=737 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Eosinophils, Baseline
|
0.161 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1350
|
0.163 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1331
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Eosinophils, On-Therapy
|
0.006 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0841
|
0.013 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0814
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Eosinophils, Test of Cure
|
0.015 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0906
|
0.018 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1081
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Basophils, Baseline
|
0.054 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0227
|
0.053 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0228
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Basophils, On-Therapy
|
-0.001 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0195
|
0.001 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0194
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Basophils, Test of Cure
|
0.000 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0209
|
0.001 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0183
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Lymphocytes, Baseline
|
2.091 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.6954
|
2.121 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.7122
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Lymphocytes, On-Therapy
|
-0.018 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.4523
|
-0.076 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.5051
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Lymphocytes, Test of Cure
|
-0.010 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.5292
|
0.059 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.5839
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Monocytes, Baseline
|
0.529 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1803
|
0.525 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1790
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Monocytes, On-Therapy
|
-0.020 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1487
|
0.003 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1711
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Monocytes, Test of Cure
|
-0.029 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1731
|
-0.012 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1778
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Neutrophils, Baseline
|
4.582 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.8893
|
4.755 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.8821
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Neutrophils, On-Therapy
|
-0.490 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.6201
|
-0.453 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.7453
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Neutrophils, Test of Cure
|
-0.534 Giga cells per Liter (10^9 cells/L)
Standard Deviation 2.0207
|
-0.494 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.9072
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Platelets, Baseline
|
280.3 Giga cells per Liter (10^9 cells/L)
Standard Deviation 68.46
|
287.2 Giga cells per Liter (10^9 cells/L)
Standard Deviation 73.51
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Platelets, On-Therapy
|
-1.1 Giga cells per Liter (10^9 cells/L)
Standard Deviation 33.03
|
-2.5 Giga cells per Liter (10^9 cells/L)
Standard Deviation 36.67
|
|
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Platelets, Test of Cure
|
6.8 Giga cells per Liter (10^9 cells/L)
Standard Deviation 42.12
|
5.5 Giga cells per Liter (10^9 cells/L)
Standard Deviation 58.04
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=739 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=737 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hemoglobin Level
Baseline
|
132.5 Gram per Liter (g/L)
Standard Deviation 13.25
|
131.7 Gram per Liter (g/L)
Standard Deviation 14.28
|
|
Change From Baseline in Hematology Parameter: Hemoglobin Level
On-Therapy
|
-1.5 Gram per Liter (g/L)
Standard Deviation 6.74
|
-1.9 Gram per Liter (g/L)
Standard Deviation 6.82
|
|
Change From Baseline in Hematology Parameter: Hemoglobin Level
Test of Cure
|
-1.3 Gram per Liter (g/L)
Standard Deviation 7.44
|
-1.4 Gram per Liter (g/L)
Standard Deviation 8.33
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=739 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=737 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Baseline
|
0.4314 Percentage of hematocrit
Standard Deviation 0.04146
|
0.4292 Percentage of hematocrit
Standard Deviation 0.04348
|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
On-Therapy
|
-0.0033 Percentage of hematocrit
Standard Deviation 0.02832
|
-0.0041 Percentage of hematocrit
Standard Deviation 0.02715
|
|
Change From Baseline in Hematology Parameter: Hematocrit Level
Test of Cure
|
-0.0045 Percentage of hematocrit
Standard Deviation 0.02806
|
-0.0029 Percentage of hematocrit
Standard Deviation 0.03194
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=739 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=737 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count
Baseline
|
4.539 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.4211
|
4.539 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.4379
|
|
Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count
On-Therapy
|
-0.046 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.2309
|
-0.060 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.2513
|
|
Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count
Test of Cure
|
-0.038 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.2634
|
-0.049 Tera cells per Liter (10^12 cells/L)
Standard Deviation 0.3052
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=739 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=737 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Test of Cure
|
-0.04 Picogram (pg)
Standard Deviation 0.780
|
0.02 Picogram (pg)
Standard Deviation 0.917
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Baseline
|
29.28 Picogram (pg)
Standard Deviation 2.537
|
29.09 Picogram (pg)
Standard Deviation 2.644
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
On-Therapy
|
-0.02 Picogram (pg)
Standard Deviation 0.795
|
-0.02 Picogram (pg)
Standard Deviation 0.820
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=739 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=737 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Baseline
|
95.30 Femtolitre (fL)
Standard Deviation 7.191
|
94.82 Femtolitre (fL)
Standard Deviation 7.511
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
On-Therapy
|
0.26 Femtolitre (fL)
Standard Deviation 4.287
|
0.35 Femtolitre (fL)
Standard Deviation 4.303
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Test of Cure
|
-0.15 Femtolitre (fL)
Standard Deviation 4.049
|
0.39 Femtolitre (fL)
Standard Deviation 4.730
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=781 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=777 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Urea Nitrogen, Test of Cure
|
0.022 millimoles per liter (mmol/L)
Standard Deviation 1.4000
|
0.131 millimoles per liter (mmol/L)
Standard Deviation 1.4826
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Glucose, Baseline
|
5.590 millimoles per liter (mmol/L)
Standard Deviation 1.9980
|
5.719 millimoles per liter (mmol/L)
Standard Deviation 2.1915
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Magnesium, Baseline
|
0.839 millimoles per liter (mmol/L)
Standard Deviation 0.0749
|
0.835 millimoles per liter (mmol/L)
Standard Deviation 0.0802
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Urea Nitrogen, Baseline
|
4.742 millimoles per liter (mmol/L)
Standard Deviation 2.1107
|
4.724 millimoles per liter (mmol/L)
Standard Deviation 1.8645
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Urea Nitrogen, On- Therapy
|
-0.056 millimoles per liter (mmol/L)
Standard Deviation 1.4269
|
-0.018 millimoles per liter (mmol/L)
Standard Deviation 1.1663
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Calcium, Baseline
|
2.363 millimoles per liter (mmol/L)
Standard Deviation 0.1196
|
2.362 millimoles per liter (mmol/L)
Standard Deviation 0.1083
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Calcium, On-Therapy
|
-0.010 millimoles per liter (mmol/L)
Standard Deviation 0.0950
|
-0.018 millimoles per liter (mmol/L)
Standard Deviation 0.0944
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Calcium, Test of Cure
|
-0.014 millimoles per liter (mmol/L)
Standard Deviation 0.1070
|
-0.016 millimoles per liter (mmol/L)
Standard Deviation 0.0981
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Chloride, Baseline
|
101.0 millimoles per liter (mmol/L)
Standard Deviation 3.27
|
100.9 millimoles per liter (mmol/L)
Standard Deviation 3.27
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Chloride, On-Therapy
|
0.3 millimoles per liter (mmol/L)
Standard Deviation 2.80
|
0.1 millimoles per liter (mmol/L)
Standard Deviation 2.85
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Chloride, Test of Cure
|
0.4 millimoles per liter (mmol/L)
Standard Deviation 2.93
|
0.4 millimoles per liter (mmol/L)
Standard Deviation 3.02
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Glucose, On-Therapy
|
0.230 millimoles per liter (mmol/L)
Standard Deviation 1.5120
|
0.328 millimoles per liter (mmol/L)
Standard Deviation 1.9380
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Glucose, Test of Cure
|
0.215 millimoles per liter (mmol/L)
Standard Deviation 1.4412
|
0.266 millimoles per liter (mmol/L)
Standard Deviation 1.6667
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Magnesium, On-Therapy
|
-0.001 millimoles per liter (mmol/L)
Standard Deviation 0.0635
|
-0.015 millimoles per liter (mmol/L)
Standard Deviation 0.0616
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Magnesium, Test of Cure
|
-0.011 millimoles per liter (mmol/L)
Standard Deviation 0.0674
|
-0.015 millimoles per liter (mmol/L)
Standard Deviation 0.0689
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Potassium, Baseline
|
4.32 millimoles per liter (mmol/L)
Standard Deviation 0.414
|
4.27 millimoles per liter (mmol/L)
Standard Deviation 0.415
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Potassium, On-Therapy
|
-0.04 millimoles per liter (mmol/L)
Standard Deviation 0.417
|
-0.03 millimoles per liter (mmol/L)
Standard Deviation 0.428
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Potassium, Test of Cure
|
-0.03 millimoles per liter (mmol/L)
Standard Deviation 0.438
|
0.00 millimoles per liter (mmol/L)
Standard Deviation 0.461
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Phosphate, Baseline
|
1.141 millimoles per liter (mmol/L)
Standard Deviation 0.1828
|
1.139 millimoles per liter (mmol/L)
Standard Deviation 0.1725
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Phosphate, On-Therapy
|
-0.005 millimoles per liter (mmol/L)
Standard Deviation 0.1782
|
-0.027 millimoles per liter (mmol/L)
Standard Deviation 0.1836
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Phosphate, Test of Cure
|
0.002 millimoles per liter (mmol/L)
Standard Deviation 0.1851
|
-0.004 millimoles per liter (mmol/L)
Standard Deviation 0.1939
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Sodium, Baseline
|
138.8 millimoles per liter (mmol/L)
Standard Deviation 2.64
|
138.8 millimoles per liter (mmol/L)
Standard Deviation 2.76
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Sodium, On-Therapy
|
0.0 millimoles per liter (mmol/L)
Standard Deviation 2.64
|
-0.2 millimoles per liter (mmol/L)
Standard Deviation 2.64
|
|
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Serum Sodium, Test of Cure
|
0.2 millimoles per liter (mmol/L)
Standard Deviation 2.91
|
0.1 millimoles per liter (mmol/L)
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=779 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=776 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
Serum Direct Bilirubin, Baseline
|
4.61 micromoles per Liter (umol/L)
Standard Deviation 1.669
|
4.47 micromoles per Liter (umol/L)
Standard Deviation 1.128
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
Serum Direct Bilirubin, On- Therapy
|
-0.18 micromoles per Liter (umol/L)
Standard Deviation 1.192
|
-0.18 micromoles per Liter (umol/L)
Standard Deviation 1.114
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
Serum Direct Bilirubin, Test of Cure
|
-0.19 micromoles per Liter (umol/L)
Standard Deviation 1.059
|
0.15 micromoles per Liter (umol/L)
Standard Deviation 1.288
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
Serum Total Bilirubin, Baseline
|
6.57 micromoles per Liter (umol/L)
Standard Deviation 3.940
|
6.56 micromoles per Liter (umol/L)
Standard Deviation 3.518
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
Serum Total Bilirubin, On-Therapy
|
-0.28 micromoles per Liter (umol/L)
Standard Deviation 2.510
|
-0.42 micromoles per Liter (umol/L)
Standard Deviation 2.672
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
Serum Total Bilirubin, Test of Cure
|
-0.01 micromoles per Liter (umol/L)
Standard Deviation 2.976
|
-0.29 micromoles per Liter (umol/L)
Standard Deviation 3.230
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
Serum Creatinine, Baseline
|
58.8 micromoles per Liter (umol/L)
Standard Deviation 30.59
|
58.1 micromoles per Liter (umol/L)
Standard Deviation 17.22
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
Serum Creatinine, On-Therapy
|
0.8 micromoles per Liter (umol/L)
Standard Deviation 30.31
|
0.3 micromoles per Liter (umol/L)
Standard Deviation 10.31
|
|
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
Serum Creatinine, Test of Cure
|
1.7 micromoles per Liter (umol/L)
Standard Deviation 14.00
|
1.5 micromoles per Liter (umol/L)
Standard Deviation 13.40
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=781 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=777 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels
Serum Albumin, Baseline
|
45.2 gram per Liter (g/L)
Standard Deviation 3.33
|
45.2 gram per Liter (g/L)
Standard Deviation 3.11
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels
Serum Albumin, On-Therapy
|
-0.4 gram per Liter (g/L)
Standard Deviation 2.38
|
-0.8 gram per Liter (g/L)
Standard Deviation 2.56
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels
Serum Albumin, Test of Cure
|
-0.5 gram per Liter (g/L)
Standard Deviation 2.65
|
-0.6 gram per Liter (g/L)
Standard Deviation 2.84
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels
Serum Protein, Baseline
|
71.5 gram per Liter (g/L)
Standard Deviation 5.12
|
71.6 gram per Liter (g/L)
Standard Deviation 4.72
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels
Serum Protein, On-Therapy
|
-0.7 gram per Liter (g/L)
Standard Deviation 3.71
|
-1.2 gram per Liter (g/L)
Standard Deviation 3.89
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels
Serum Protein, Test of Cure
|
-1.0 gram per Liter (g/L)
Standard Deviation 4.19
|
-1.1 gram per Liter (g/L)
Standard Deviation 4.32
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=777 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=774 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
Serum AST, Test of Cure
|
0.9 Units per Liter (U/L)
Standard Deviation 9.89
|
-0.5 Units per Liter (U/L)
Standard Deviation 8.29
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
Serum ALT, Baseline
|
20.3 Units per Liter (U/L)
Standard Deviation 20.34
|
19.5 Units per Liter (U/L)
Standard Deviation 14.66
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
Serum ALT, On-Therapy
|
0.2 Units per Liter (U/L)
Standard Deviation 10.8
|
-0.1 Units per Liter (U/L)
Standard Deviation 7.9
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
Serum ALT, Test of Cure
|
0.4 Units per Liter (U/L)
Standard Deviation 15.81
|
-0.2 Units per Liter (U/L)
Standard Deviation 9.93
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
Serum AST, Baseline
|
21.0 Units per Liter (U/L)
Standard Deviation 13.72
|
20.2 Units per Liter (U/L)
Standard Deviation 10.48
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
Serum AST, On-Therapy
|
0.1 Units per Liter (U/L)
Standard Deviation 9.83
|
0.0 Units per Liter (U/L)
Standard Deviation 7.90
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
Serum ALP, Baseline
|
81.4 Units per Liter (U/L)
Standard Deviation 29.96
|
81.7 Units per Liter (U/L)
Standard Deviation 28.99
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
Serum ALP, On- Therapy
|
-0.5 Units per Liter (U/L)
Standard Deviation 9.61
|
-0.1 Units per Liter (U/L)
Standard Deviation 12.91
|
|
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
Serum ALP, Test of Cure
|
-1.0 Units per Liter (U/L)
Standard Deviation 12.00
|
-0.4 Units per Liter (U/L)
Standard Deviation 15.38
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Protein (PRO), Urine Occult Blood (BLO), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Leukocyte Esterase (LEU). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, Small, Moderate, Large, Positive, 50 milligram per deciliter (mg/dL), 150 mg/dL, \>=500 mg/dL, 30 mg/dL, 100 mg/dL, 200 mg/dL, 5 mg/dL, 20 mg/dL, \>=80 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, Negative), GLU indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Data is presented in similar way for others parameters.
Outcome measures
| Measure |
Gepotidacin
n=789 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=783 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Urinalysis Dipstick Results
KET, Baseline, 20 mg/dL
|
11 Participants
|
7 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
NIT, Baseline, Positive
|
237 Participants
|
252 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
NIT, On-Therapy, Positive
|
37 Participants
|
40 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, Baseline, Negative
|
245 Participants
|
232 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
KET, On-Therapy, Negative
|
712 Participants
|
699 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
KET, On-Therapy, 5 mg/dL
|
14 Participants
|
22 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
KET, On-Therapy, 20 mg/dL
|
5 Participants
|
15 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
KET, On-Therapy, >=80 mg/dL
|
0 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
KET, Test of Cure, Negative
|
706 Participants
|
700 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
KET, Test of Cure, 5 mg/dL
|
7 Participants
|
20 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
KET, Test of Cure, 20 mg/dL
|
6 Participants
|
7 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
NIT, Baseline, Negative
|
552 Participants
|
531 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
NIT, On-Therapy, Negative
|
694 Participants
|
697 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
NIT, Test of Cure, Negative
|
697 Participants
|
669 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
NIT, Test of Cure, Positive
|
22 Participants
|
58 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, Test of Cure, >=500 mg/dL
|
1 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, Baseline, Trace
|
96 Participants
|
91 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, Baseline, Small
|
75 Participants
|
80 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, Baseline, Moderate
|
120 Participants
|
116 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, Baseline, Large
|
251 Participants
|
262 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, Baseline, Missing
|
2 Participants
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, On-Therapy, Negative
|
510 Participants
|
475 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, On-Therapy, Trace
|
79 Participants
|
82 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, On-Therapy, Small
|
50 Participants
|
49 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, On-Therapy, Moderate
|
34 Participants
|
57 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, On-Therapy, Large
|
58 Participants
|
74 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, Test of Cure, Negative
|
526 Participants
|
494 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, Test of Cure, Trace
|
61 Participants
|
49 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, Test of Cure, Small
|
43 Participants
|
48 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, Test of Cure, Moderate
|
35 Participants
|
59 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
LEU, Test of Cure, Large
|
54 Participants
|
77 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, Baseline, Negative
|
751 Participants
|
738 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, Baseline, 50 mg/dL
|
4 Participants
|
5 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, Baseline, 150 mg/dL
|
3 Participants
|
4 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, Baseline, >= 500 mg/dL
|
21 Participants
|
26 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, On-Therapy, Negative
|
700 Participants
|
697 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, On-Therapy, 50 mg/dL
|
7 Participants
|
7 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, On-Therapy, 150 mg/dL
|
1 Participants
|
5 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, On-Therapy, >= 500 mg/dL
|
23 Participants
|
28 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, Test of Cure, Negative
|
686 Participants
|
693 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, Test of Cure, 50 mg/dL
|
9 Participants
|
10 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, Test of Cure, 150 mg/dL
|
12 Participants
|
4 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
GLU, Test of Cure, >= 500 mg/dL
|
12 Participants
|
20 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, Baseline, Negative
|
524 Participants
|
529 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, Baseline, 30 mg/dL
|
171 Participants
|
149 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, Baseline, 100 mg/dL
|
78 Participants
|
85 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, Baseline, >=500 mg/dL
|
5 Participants
|
6 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, On-Therapy, Negative
|
575 Participants
|
631 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, On-Therapy, 30 mg/dL
|
110 Participants
|
83 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, On-Therapy, 100 mg/dL
|
43 Participants
|
19 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, On-Therapy, >=500 mg/dL
|
3 Participants
|
4 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, Test of Cure, Negative
|
605 Participants
|
605 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, Test of Cure, 30 mg/dL
|
88 Participants
|
88 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
PRO, Test of Cure, 100 mg/dL
|
25 Participants
|
34 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, Baseline, Positive
|
0 Participants
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, Baseline, Negative
|
345 Participants
|
348 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, Baseline, Trace
|
2 Participants
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, Baseline, Small
|
229 Participants
|
217 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, Baseline, Moderate
|
128 Participants
|
129 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, Baseline, Large
|
80 Participants
|
81 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, On-Therapy, Negative
|
560 Participants
|
520 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, On-Therapy, Small
|
116 Participants
|
161 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, Test of Cure, Moderate
|
49 Participants
|
45 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, On-Therapy, Moderate
|
23 Participants
|
30 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, On-Therapy, Large
|
32 Participants
|
26 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, Test of Cure, Negative
|
517 Participants
|
511 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, Test of Cure, Small
|
128 Participants
|
139 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
BLO, Test of Cure, Large
|
25 Participants
|
32 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
KET, Baseline, Negative
|
754 Participants
|
748 Participants
|
|
Number of Participants With Urinalysis Dipstick Results
KET, Baseline, 5 mg/dL
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected from participants to assess urine specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=779 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=773 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Absolute Mean Values of Urine Specific Gravity
Baseline
|
1.0172 Ratio
Standard Deviation 0.00693
|
1.0174 Ratio
Standard Deviation 0.00686
|
|
Absolute Mean Values of Urine Specific Gravity
On-Therapy
|
1.0176 Ratio
Standard Deviation 0.00716
|
1.0167 Ratio
Standard Deviation 0.00696
|
|
Absolute Mean Values of Urine Specific Gravity
Test of Cure
|
1.0179 Ratio
Standard Deviation 0.00712
|
1.0179 Ratio
Standard Deviation 0.00719
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected from participants to assess urine pH levels. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=763 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=764 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Absolute Mean Values of Urine Potential of Hydrogen (pH)
pH, Baseline
|
5.7 pH
Standard Deviation 0.8
|
5.7 pH
Standard Deviation 0.79
|
|
Absolute Mean Values of Urine Potential of Hydrogen (pH)
pH, On-Therapy
|
5.6 pH
Standard Deviation 0.66
|
5.6 pH
Standard Deviation 0.69
|
|
Absolute Mean Values of Urine Potential of Hydrogen (pH)
pH, Test of Cure
|
5.6 pH
Standard Deviation 0.69
|
5.7 pH
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=804 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=798 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
SBP, Baseline
|
122 Millimeters of mercury (mmHg)
Standard Deviation 13.33
|
122.7 Millimeters of mercury (mmHg)
Standard Deviation 13.98
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
SBP, On-Therapy
|
-1.1 Millimeters of mercury (mmHg)
Standard Deviation 10.14
|
-1.1 Millimeters of mercury (mmHg)
Standard Deviation 10.72
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
SBP, Test of Cure
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 11.67
|
-1.8 Millimeters of mercury (mmHg)
Standard Deviation 12.19
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
DBP, Baseline
|
76.9 Millimeters of mercury (mmHg)
Standard Deviation 8.17
|
77 Millimeters of mercury (mmHg)
Standard Deviation 9
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
DBP, On-Therapy
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 7.30
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 7.73
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
DBP, Test of Cure
|
-0.1 Millimeters of mercury (mmHg)
Standard Deviation 7.98
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 8.37
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=804 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=798 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit
Pulse rate, Baseline
|
73.2 beats per minute (bpm)
Standard Deviation 9.64
|
73.7 beats per minute (bpm)
Standard Deviation 10.32
|
|
Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit
Pulse rate, On-Therapy
|
0.9 beats per minute (bpm)
Standard Deviation 8.24
|
1.3 beats per minute (bpm)
Standard Deviation 8.66
|
|
Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit
Pulse rate, Test of Cure
|
1.8 beats per minute (bpm)
Standard Deviation 9.74
|
1.7 beats per minute (bpm)
Standard Deviation 9.95
|
SECONDARY outcome
Timeframe: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Gepotidacin
n=804 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=798 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Change From Baseline in Body Temperature
Temperature, Test of Cure
|
-0.01 Celsius
Standard Deviation 0.349
|
-0.04 Celsius
Standard Deviation 0.351
|
|
Change From Baseline in Body Temperature
Temperature, Baseline
|
36.61 Celsius
Standard Deviation 0.346
|
36.63 Celsius
Standard Deviation 0.317
|
|
Change From Baseline in Body Temperature
Temperature, On-Therapy
|
-0.01 Celsius
Standard Deviation 0.334
|
-0.01 Celsius
Standard Deviation 0.372
|
SECONDARY outcome
Timeframe: Up to Day 31Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles \<=450, \>450 to \<=480, \>480 to \<=500 millisecond (msec) are the values at baseline. The category titles \<= 30, 31-60, \>60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented.
Outcome measures
| Measure |
Gepotidacin
n=791 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=784 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
<= 450 msec · <=30 msec
|
675 Participants
|
700 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
<= 450 msec · 31-60 msec
|
23 Participants
|
12 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
<= 450 msec · >60 msec
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
<= 450 msec · Missing
|
47 Participants
|
31 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
>450 to <=480 msec · <=30 msec
|
40 Participants
|
37 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
>450 to <=480 msec · 31-60 msec
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
>450 to <=480 msec · >60 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
>450 to <=480 msec · Missing
|
3 Participants
|
3 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
>480 to <=500 msec · <=30 msec
|
—
|
1 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
>480 to <=500 msec · 31-60 msec
|
—
|
0 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
>480 to <=500 msec · >60 msec
|
—
|
0 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
>480 to <=500 msec · Missing
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 31Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles \<=450 msec, \>450 msec to \<=480 msec are the values at baseline. The category titles \<= 30, 31-60, \>60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented.
Outcome measures
| Measure |
Gepotidacin
n=791 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=784 Participants
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline
>450 to <=480 msec · 31-60 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline
>450 to <=480 msec · Missing
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline
<= 450 msec · <=30 msec
|
721 Participants
|
742 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline
<= 450 msec · 31-60 msec
|
12 Participants
|
4 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline
<= 450 msec · >60 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline
<= 450 msec · Missing
|
50 Participants
|
33 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline
>450 to <=480 msec · <=30 msec
|
8 Participants
|
4 Participants
|
|
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline
>450 to <=480 msec · >60 msec
|
0 Participants
|
0 Participants
|
Adverse Events
Gepotidacin
Serious events: 5 serious events
Other events: 235 other events
Deaths: 0 deaths
Nitrofurantoin
Serious events: 5 serious events
Other events: 119 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gepotidacin
n=804 participants at risk
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=798 participants at risk
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Cardiac disorders
Atrial fribrillation
|
0.12%
1/804 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.00%
0/798 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.12%
1/804 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.00%
0/798 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.12%
1/804 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.00%
0/798 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/804 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.13%
1/798 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.25%
2/804 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.00%
0/798 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/804 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.25%
2/798 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/804 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.13%
1/798 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/804 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.13%
1/798 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Gepotidacin
n=804 participants at risk
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
Nitrofurantoin
n=798 participants at risk
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
18.3%
147/804 • Number of events 166 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
3.0%
24/798 • Number of events 25 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
8.1%
65/804 • Number of events 66 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
4.4%
35/798 • Number of events 36 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
3.5%
28/804 • Number of events 29 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.50%
4/798 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Faeces soft
|
2.9%
23/804 • Number of events 30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.50%
4/798 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
18/804 • Number of events 18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.88%
7/798 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
12/804 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.88%
7/798 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.1%
9/804 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.50%
4/798 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
2.6%
21/804 • Number of events 23 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
2.8%
22/798 • Number of events 27 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
2.2%
18/804 • Number of events 18 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
1.4%
11/798 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
11/804 • Number of events 11 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
1.9%
15/798 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Fungal infection
|
1.1%
9/804 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
1.3%
10/798 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
1.1%
9/804 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
0.63%
5/798 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
0.37%
3/804 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
1.0%
8/798 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Safety population included all randomized participants who receive at least 1 dose of study treatment.
|
Additional Information
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