Adults 18 to 80, any sex, with Infectious Skin Disease or Bacterial Skin Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) PopulationPrimary· 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
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 ne
Clinical success
Group
Value
95% CI
Omadacycline
75
Linezolid
59
Clinical failure
Group
Value
95% CI
Omadacycline
9
Linezolid
19
Clinical failure: failure
Group
Value
95% CI
Omadacycline
2
Linezolid
4
Clinical failure: non-evaluable
Group
Value
95% CI
Omadacycline
7
Linezolid
15
Number of Participants With Clinical Response in the Clinically Evaluable (CE) PopulationPrimary· 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
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
Clinical success
Group
Value
95% CI
Omadacycline
98
Linezolid
82
Clinical failure
Group
Value
95% CI
Omadacycline
2
Linezolid
6
Number of Participants With Microbiologic Response in the mITT PopulationSecondary· 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
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.
Microbiological success
Group
Value
95% CI
Omadacycline
73
Linezolid
57
Microbiological failure
Group
Value
95% CI
Omadacycline
11
Linezolid
21
Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) PopulationSecondary· 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
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.
Microbiological success
Group
Value
95% CI
Omadacycline
73
Linezolid
57
Microbiological failure
Group
Value
95% CI
Omadacycline
4
Linezolid
6
Adverse events — posted to ClinicalTrials.gov
Time frame: from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days).
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT00865280 — Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
· Phase 3
· terminated
Other Paratek Pharmaceuticals Inc trials
Trials by the same sponsor.
NCT05217537 — Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Inf
· Phase 1
· completed
NCT04922554 — Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
· Phase 2
· completed
NCT04779242 — Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
· Phase 3
· completed
NCT04160260 — Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia
· Phase 1
· completed
NCT03757234 — IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Paratek Pharmaceuticals Inc
Last refreshed: 12 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03716024.