NCT00270517

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 19, 2006

Status Verified

September 1, 2006

First QC Date

December 23, 2005

Last Update Submit

September 18, 2006

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Clinical Cure 7-14 days after end of therapy

Secondary Outcomes (4)

  • Bacteriological response

  • Radiographic response

  • Change in signs and symptoms

  • Safety

Interventions

EDP-420 / Duration of Treatment - 3 daysDRUG
Telithromycin / Duration of Treatment - 7 daysDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Enanta Pharmaceuticals, Inc.

Watertown, Massachusetts, 02472, United States

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

EDP 420Duration of Therapytelithromycin

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Study Director

    Enanta Pharmaceuticals, Inc

    STUDY DIRECTOR

Central Study Contacts

Medical Director

CONTACT

clinical@enanta.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 23, 2005

First Posted

December 28, 2005

Study Start

December 1, 2005

Study Completion

July 1, 2007

Last Updated

September 19, 2006

Record last verified: 2006-09

Locations

US(1)