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

Enanta Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Community Acquired Pneumonia

Treatments: Drug: Telithromycin / Duration of Treatment - 7 days; Drug: EDP-420 / Duration of Treatment - 3 days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00270517

EDP420-05-006

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind