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

Community Acquired Pneumonia Clinical Trial

Official title:

A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00270517
• Other study ID #: EDP420-05-006
• Status: Recruiting
• Phase: Phase 2
• First received: December 23, 2005
• Last updated: September 18, 2006
• Start date: December 2005
• Est. completion date: July 2007

Study information

• Verified date: September 2006
• Source: Enanta Pharmaceuticals
• Contact: Medical Director
• Email: clinical[@]enanta.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Intervention

Drug:
• EDP-420 / Duration of Treatment – 3 days

• Telithromycin / Duration of Treatment – 7 days

Locations

Country	Name	City	State
United States	Enanta Pharmaceuticals, Inc.	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure 7-14 days after end of therapy
Secondary	Bacteriological response
Secondary	Radiographic response
Secondary	Change in signs and symptoms
Secondary	Safety