Phase 3
Completed N=670
Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
Source: ClinicalTrials.gov NCT04779242 ↗Enrolled (actual)
670
Serious AEs
4.8%
Results posted
Apr 2025
Primary outcomePrimary: Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit — 89.6; 87.7; 8.6; 9.3 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit |
89.6; 87.7; 8.6; 9.3; 1.8; 3.0 | — |
| SECONDARY Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit |
86; 87.7; 8.0; 6.6; 6.0; 5.7 | — |
| SECONDARY Percentage of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population at the PTE Visit |
94.1; 95.9; 5.9; 4.1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects, age 18 or older who have signed the informed consent form
- Must have a qualifying community-acquired bacterial pneumonia
- Subjects must not be pregnant or nursing 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
- Confirmed or suspected SARS-CoV-2 infection
- Evidence of significant immunological disease
- Has a life expectancy of less than or equal to 3 months or any concomitant condition that is likely to interfere with evaluation of the response of the infection under study, determination of AEs, or completion of the expected course of treatment
- Has a history of contraindications, hypersensitivity, or allergic reaction to any tetracycline or fluoroquinolone antibiotic
- Has received an investigational drug within the past 30 days
Data sourced from ClinicalTrials.gov (NCT04779242). 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. Informational only — not medical advice.