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

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-23
• Study First Submitted QC: 2005-12-23
• Study First Posted: 2005-12-28
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-18
• Last Update Posted: 2006-09-19
• Study Completion: 2007-07

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