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

Completed · Phase 3

Conditions studied: Bacterial Infections

In brief

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

Key facts

Study ID

NCT00035854

Run by

Pfizer

People needed

13

Starts

2002-02-01

Expected to finish

2004-05-01

Last updated by the study team

2009-08-14

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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