Status:

UNKNOWN

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

Lead Sponsor:

Enanta Pharmaceuticals, Inc

Conditions:

Community Acquired Pneumonia

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2005

Trial Type :

INTERVENTIONAL

End Date :

July 1 2007

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT00270517

Start Date

December 1 2005

End Date

July 1 2007

Last Update

September 19 2006

Active Locations (1)

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1

Enanta Pharmaceuticals, Inc.

Watertown, Massachusetts, United States, 02472