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Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia
This study is currently recruiting participants.
Verified by Enanta Pharmaceuticals, September 2006
Sponsored by: Enanta Pharmaceuticals
Information provided by: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00270517
  Purpose

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


Condition Intervention Phase
Community Acquired Pneumonia
Drug: EDP-420 / Duration of Treatment – 3 days
Drug: Telithromycin / Duration of Treatment – 7 days
Phase II

MedlinePlus related topics: Antibiotics Pneumonia
Drug Information available for: Telithromycin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia

Further study details as provided by Enanta Pharmaceuticals:

Primary Outcome Measures:
  • Clinical Cure 7-14 days after end of therapy

Secondary Outcome Measures:
  • Bacteriological response
  • Radiographic response
  • Change in signs and symptoms
  • Safety

Estimated Enrollment: 250
Study Start Date: December 2005
Estimated Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270517

Contacts
Contact: Medical Director clinical@enanta.com

Locations
United States, Massachusetts
Enanta Pharmaceuticals, Inc. Recruiting
Watertown, Massachusetts, United States, 02472
Contact: Study Director         clinical@enanta.com    
Sponsors and Collaborators
Enanta Pharmaceuticals
Investigators
Study Director: Study Director Enanta Pharmaceuticals, Inc
  More Information

Study ID Numbers: EDP420-05-006
Study First Received: December 23, 2005
Last Updated: September 18, 2006
ClinicalTrials.gov Identifier: NCT00270517  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Telithromycin
Pneumonia

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009