Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia

• Status: Unknown status
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enanta Pharmaceuticals
• Treatments: Telithromycin

Criteria

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