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
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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COMPLETED
PHASE3
13 participants
INTERVENTIONAL
2002-02-28
2004-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Zyvox® / Linezolid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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Research Center
Long Beach, California, United States
Research Center
Los Angeles, California, United States
Research Center
Los Angeles, California, United States
Research Center
Hartford, Connecticut, United States
Research Center
Washington D.C., District of Columbia, United States
Research Center
Gainesville, Florida, United States
Research Center
Atlanta, Georgia, United States
Research Center
Chicago, Illinois, United States
Research Center
Park Ridge, Illinois, United States
Research Center
Louisville, Kentucky, United States
Research Center
Baltimore, Maryland, United States
Research Center
Boston, Massachusetts, United States
Research Center
Detroit, Michigan, United States
Research Center
Camden, New Jersey, United States
Research Center
New York, New York, United States
Research Center
New York, New York, United States
Research Center
New York, New York, United States
Research Center
Cleveland, Ohio, United States
Research Center
Danville, Pennsylvania, United States
Research Center
Philadelphia, Pennsylvania, United States
Research Center
Austin, Texas, United States
Countries
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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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