Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/18/2019 |
| Start Date: | November 2015 |
| End Date: | March 10, 2017 |
A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia
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.
to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.
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
We found this trial at
13
sites
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