New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)

NCT ID: NCT00035854

Last Updated: 2009-08-14

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2004-05-31

Brief Summary

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This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)

Detailed Description

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Conditions

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Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zyvox® / Linezolid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hospitalized/chronic care pediatric patients (birth through 17 years)
* Known infections due to vancomycin-resistant enterococcus species, including diagnosis of hospital-acquired pneumonia, complicated skin and skin structure infections, catheter-related bacteremia, bacteremia of unidentified source, and other infections
* Requires a minimum of 3 days of IV medication
* Patients with mixed infections due to VRE \& gram negative bacteria are allowed to enroll in the study. For most of the infections, 2 or more of additional symptoms are required.

Exclusion Criteria

* Potentially effective concomitant antibiotic
* A high surgical cure rate
* Medical conditions which would preclude clinical evaluation or require treatment of longer duration than 28 days
* 24 hours of antibiotic treatment within 48 hours of study entry (unless pre-approved)
* Having an infected device that could not be removed
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Locations

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Research Center

Long Beach, California, United States

Site Status

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Los Angeles, California, United States

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Los Angeles, California, United States

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Hartford, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Gainesville, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Park Ridge, Illinois, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Camden, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Cleveland, Ohio, United States

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Danville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Countries

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United States

Other Identifiers

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A5951062

Identifier Type: -

Identifier Source: secondary_id

M12600082VRE

Identifier Type: -

Identifier Source: org_study_id

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