search
Back to results

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

Primary Purpose

Community Acquired Pneumonia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EDP-420 / Duration of Treatment - 3 days
Telithromycin / Duration of Treatment - 7 days
Sponsored by
Enanta Pharmaceuticals, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community Acquired Pneumonia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Enanta Pharmaceuticals, Inc.Recruiting

Outcomes

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

Full Information

First Posted
December 23, 2005
Last Updated
September 18, 2006
Sponsor
Enanta Pharmaceuticals, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT00270517
Brief Title
Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia
Official Title
A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Enanta Pharmaceuticals, Inc

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
EDP-420 / Duration of Treatment - 3 days
Intervention Type
Drug
Intervention Name(s)
Telithromycin / Duration of Treatment - 7 days
Primary Outcome Measure Information:
Title
Clinical Cure 7-14 days after end of therapy
Secondary Outcome Measure Information:
Title
Bacteriological response
Title
Radiographic response
Title
Change in signs and symptoms
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Director
Email
clinical@enanta.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Enanta Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Enanta Pharmaceuticals, Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Director
Email
clinical@enanta.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs