- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00270517
Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia
September 18, 2006 updated by: Enanta Pharmaceuticals, Inc
A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia
This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
250
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Medical Director
- Email: clinical@enanta.com
Study Locations
-
-
Massachusetts
-
Watertown, Massachusetts, United States, 02472
- Recruiting
- Enanta Pharmaceuticals, Inc.
-
Contact:
- Study Director
- Email: clinical@enanta.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Clinical Cure 7-14 days after end of therapy
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety
|
Bacteriological response
|
Radiographic response
|
Change in signs and symptoms
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Study Director, Enanta Pharmaceuticals, Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Study Completion
July 1, 2007
Study Registration Dates
First Submitted
December 23, 2005
First Submitted That Met QC Criteria
December 23, 2005
First Posted (Estimate)
December 28, 2005
Study Record Updates
Last Update Posted (Estimate)
September 19, 2006
Last Update Submitted That Met QC Criteria
September 18, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EDP420-05-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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