Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia
Phase 2
- Conditions
- Community Acquired Pneumonia
- Registration Number
- NCT00270517
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clinical Cure 7-14 days after end of therapy
- Secondary Outcome Measures
Name Time Method Bacteriological response Radiographic response Change in signs and symptoms Safety
Trial Locations
- Locations (1)
Enanta Pharmaceuticals, Inc.
🇺🇸Watertown, Massachusetts, United States