Title
Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia
A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia
Phase
Phase 2Lead Sponsor
Enanta PharmaceuticalsStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Community Acquired PneumoniaIntervention/Treatment
modithromycin telithromycin ...Study Participants
250This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia
Inclusion Criteria: Recent respiratory illness with signs and symptoms and chest X-ray consistent with the diagnosis of community-acquired pneumonia. Suitable candidate for oral antibiotic therapy and able to swallow large capsules intact If female, must be non-lactating and at no risk for pregnancy Exclusion Criteria: Other infections Other pulmonary diseases requirement multiple antibacterial medications or long duration of therapy History of hypersensitivity, allergic or adverse reactions to macrolide, ketolide, azalide or streptogramins Evidence of uncontrolled clinically significant disease, malignancy, or other abnormality Requirement of parenteral antimicrobial therapy for treatment of pneumonia Currently receiving or likely to receive any known inhibitors or inducers of cytochrome P450 mediated drug metabolism Immunocompromised subjects
