Recruiting
Phase 2

EDP-420 vs. Antibiotic

Sponsor:

Enanta Pharmaceuticals, Inc

Code:

NCT00270517

Conditions

Community Acquired Pneumonia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

EDP-420 / Duration of Treatment - 3 days

Telithromycin / Duration of Treatment - 7 days

Study Details

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

Conditions

Community Acquired Pneumonia

Study ID

NCT00270517

Start date

Dec, 2005

Status verified date

Sep, 2006

Completion date

Jul, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

EDP-420 / Duration of Treatment - 3 days

Telithromycin / Duration of Treatment - 7 days

Primary outcome measure

  • Clinical Cure 7-14 days after end of therapy [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Medical Director

clinical@enanta.com

Locations

Enanta Pharmaceuticals, Inc.

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

Study Director

clinical@enanta.com

More Information

Sponsor

Enanta Pharmaceuticals, Inc

Last update posted

Sep 19, 2006

Last verified

Sep, 2006

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Enanta Pharmaceuticals, Inc on 2006-09-19.