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

NCT ID: NCT00270517

Last Updated: 2006-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-07-31

Brief Summary

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This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia

Detailed Description

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Conditions

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Community Acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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EDP-420 / Duration of Treatment - 3 days

Intervention Type DRUG

Telithromycin / Duration of Treatment - 7 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Locations

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Enanta Pharmaceuticals, Inc.

Watertown, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Medical Director

Role: CONTACT

Email: [email protected]

Facility Contacts

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Study Director

Role: primary

Other Identifiers

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EDP420-05-006

Identifier Type: -

Identifier Source: org_study_id