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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Enanta Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Enanta Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00270517
First received: December 23, 2005
Last updated: September 18, 2006
Last verified: September 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014