A Phase 3b Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects With Community-Acquired Bacterial Pneumonia (CABP)

PTK0796-CABP-19302

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.

2021-02-25

2024-04-01

2024-04-01

Active (not recruiting)

Early phase I

670

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 670, 'type': 'ESTIMATED'}}

2024-03-15