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

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ClinicalTrials.gov 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
Sponsor:
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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov 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:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents