Phase 3
N=655
Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
Bacterial Infections · Skin Structures and Soft Tissue Infections
Bottom Line
View on ClinicalTrials.gov: NCT02378480 ↗Enrolled (actual)
655
Serious AEs
3.1%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants With Early Clinical Response — 268; 266; 23; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omadacycline (Drug); Linezolid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Paratek Pharmaceuticals Inc
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Early Clinical Response |
268; 266; 23; 19; 25; 26 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit |
272; 260; 20; 27; 24; 24 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population |
259; 243; 10; 17 | — |
| SECONDARY Number of Participants With the Indicated Type of Adverse Event (AE) |
158; 157; 156; 147; 58; 59 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.
Eligibility Criteria
Inclusion Criteria
- Patients, ages 18 years or older who have signed the informed consent
- Has a qualifying skin and skin structure infection
- Female patients must not be pregnant at the time of enrollment
- Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
Exclusion Criteria
- Infections where the outcome is strongly influenced by factors other than protocol-defined treatment and procedures, that require antibacterial treatment for greater than 14 days
- Evidence of significant immunological disease
- Severe sepsis or septic shock
- Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
- Has received an investigational drug within past 30 days
- Women who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT02378480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.