Phase 3
N=774
Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
Bacterial Pneumonia · Community-Acquired Infections
Bottom Line
View on ClinicalTrials.gov: NCT02531438 ↗Enrolled (actual)
774
Serious AEs
6.4%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Early Clinical Response — 313; 321; 49; 47 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omadacycline (Drug); Moxifloxacin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Paratek Pharmaceuticals Inc
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Early Clinical Response |
313; 321; 49; 47; 24; 20 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) Visit |
338; 330; 32; 42; 16; 16 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CT-PTE) Population |
316; 312; 24; 33 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.
Eligibility Criteria
Inclusion Criteria
- Patients, ages 18 years or older who have signed the informed consent
- Has qualifying bacterial pneumonia
- 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
- Known or suspected hospital-acquired pneumonia
- Evidence of significant immunological disease
- Has a history of hypersensitivity or allergic reaction to any tetracycline or to any fluoroquinolone antibiotic
- Has received an investigational drug within past 30 days
- Women who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT02531438). 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.