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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00270517
Recruitment Status : Unknown
Verified September 2006 by Enanta Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : December 28, 2005
Last Update Posted : September 19, 2006
Information provided by:
Enanta Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia Drug: EDP-420 / Duration of Treatment – 3 days Drug: Telithromycin / Duration of Treatment – 7 days Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia
Study Start Date : December 2005
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Bacteriological response
  2. Radiographic response
  3. Change in signs and symptoms
  4. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00270517

Contact: Medical Director

United States, Massachusetts
Enanta Pharmaceuticals, Inc. Recruiting
Watertown, Massachusetts, United States, 02472
Contact: Study Director   
Sponsors and Collaborators
Enanta Pharmaceuticals
Study Director: Study Director Enanta Pharmaceuticals, Inc Identifier: NCT00270517     History of Changes
Other Study ID Numbers: EDP420-05-006
First Posted: December 28, 2005    Key Record Dates
Last Update Posted: September 19, 2006
Last Verified: September 2006

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Anti-Infective Agents