Trial Outcomes & Findings for Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI) (NCT NCT03716024)
NCT ID: NCT03716024
Last Updated: 2020-10-12
Results Overview
Clinical response is defined as clinical success (CS), which is categorized as a determination by a blinded evaluator (BE) that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant (par.) received ≥1 dose of test article, the par. did not receive non-study antibiotics on \>2 calendar days from Day 1 to the Test of Cure assessment, and the par. did not meet any of the criteria for clinical failure. Clinical failure (CF) is categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the par. received potentially effective antibiotics for treatment of the primary infection site on \>2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
234 participants
Primary outcome timeframe
10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Results posted on
2020-10-12
Participant Flow
Participant milestones
| Measure |
Omadacycline
Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
Linezolid
Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
116
|
|
Overall Study
COMPLETED
|
107
|
98
|
|
Overall Study
NOT COMPLETED
|
11
|
18
|
Reasons for withdrawal
| Measure |
Omadacycline
Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
Linezolid
Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
|---|---|---|
|
Overall Study
Randomized, not Treated
|
7
|
8
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Treatment Failure
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Missing Reason
|
0
|
1
|
Baseline Characteristics
Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Baseline characteristics by cohort
| Measure |
Omadacycline
n=111 Participants
Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
Linezolid
n=108 Participants
Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 14.06 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 13.34 • n=7 Participants
|
44.9 years
STANDARD_DEVIATION 13.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
97 participants
n=5 Participants
|
99 participants
n=7 Participants
|
196 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian Hawaiian or Other Pacific Islander
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Recorded as Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)Population: mITT Population: all enrolled participants who received at least 1 dose of test article and who had at least 1 infecting pathogen isolated at the Baseline evaluation. Non-evaluable participants are included as clinical failures.
Clinical response is defined as clinical success (CS), which is categorized as a determination by a blinded evaluator (BE) that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant (par.) received ≥1 dose of test article, the par. did not receive non-study antibiotics on \>2 calendar days from Day 1 to the Test of Cure assessment, and the par. did not meet any of the criteria for clinical failure. Clinical failure (CF) is categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the par. received potentially effective antibiotics for treatment of the primary infection site on \>2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
Outcome measures
| Measure |
Omadacycline
n=84 Participants
Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
Linezolid
n=78 Participants
Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
|---|---|---|
|
Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population
Clinical failure: non-evaluable
|
7 participants
|
15 participants
|
|
Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population
Clinical failure: failure
|
2 participants
|
4 participants
|
|
Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population
Clinical success
|
75 participants
|
59 participants
|
|
Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population
Clinical failure
|
9 participants
|
19 participants
|
PRIMARY outcome
Timeframe: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)Population: CE Population: all enrolled participants who received at least 1 dose of test article and who had a qualifying skin and skin structure infection, received the correct test article for at least 5 calendar days, had the necessary clinical evaluations performed, and did not receive potentially confounding non-study antibiotics
Clinical response is defined as CS, which was categorized as a determination by a BE that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant received ≥1 dose of test article, the participant did not receive non-study antibiotics on \>2 calendar days from Day 1 to the Test of Cure assessment, and the participant did not meet any of the criteria for clinical failure. CF was categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the participant received potentially effective antibiotics for treatment of the primary infection site on \>2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
Outcome measures
| Measure |
Omadacycline
n=100 Participants
Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
Linezolid
n=88 Participants
Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
|---|---|---|
|
Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population
Clinical success
|
98 participants
|
82 participants
|
|
Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population
Clinical failure
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)Population: mITT Population. Non-evaluable participants are included as microbiological failures.
Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study.
Outcome measures
| Measure |
Omadacycline
n=84 Participants
Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
Linezolid
n=78 Participants
Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
|---|---|---|
|
Number of Participants With Microbiologic Response in the mITT Population
Microbiological success
|
73 participants
|
57 participants
|
|
Number of Participants With Microbiologic Response in the mITT Population
Microbiological failure
|
11 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)Population: ME Population: all participants in the CE cohort who had an infecting pathogen identified at Baseline
Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study.
Outcome measures
| Measure |
Omadacycline
n=77 Participants
Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
Linezolid
n=63 Participants
Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
|---|---|---|
|
Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) Population
Microbiological success
|
73 participants
|
57 participants
|
|
Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) Population
Microbiological failure
|
4 participants
|
6 participants
|
Adverse Events
Omadacycline
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Linezolid
Serious events: 2 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omadacycline
n=111 participants at risk
Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
Linezolid
n=108 participants at risk
Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
|---|---|---|
|
Psychiatric disorders
Confusional state
|
0.90%
1/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.00%
0/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.93%
1/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Infections and infestations
Wound infection
|
0.00%
0/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.93%
1/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
Other adverse events
| Measure |
Omadacycline
n=111 participants at risk
Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
Linezolid
n=108 participants at risk
Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.00%
0/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Gastrointestinal disorders
Nausea
|
11.7%
13/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
7.4%
8/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
5/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
1.9%
2/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
5/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
3.7%
4/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.00%
0/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.00%
0/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
5.6%
6/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.93%
1/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
General disorders
Fatigue
|
4.5%
5/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
1.9%
2/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Infections and infestations
Abscess
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.93%
1/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
2.8%
3/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Investigations
Alanine aminotransferase (ALT) increased
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
6.5%
7/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Investigations
Aspartate aminotransaminase (AST) increased
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
4.6%
5/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.93%
1/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.6%
4/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.93%
1/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.00%
0/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.00%
0/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Nervous system disorders
Headache
|
5.4%
6/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
7.4%
8/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Nervous system disorders
Dizziness
|
3.6%
4/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
4.6%
5/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Psychiatric disorders
Insomnia
|
1.8%
2/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
2.8%
3/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
5/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
0.00%
0/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
3/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
3.7%
4/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.90%
1/111 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
2.8%
3/108 • from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
|
Additional Information
Paratek Medical Information
Paratek Pharmaceuticals, Inc.
Phone: 1-833-727-2835
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60