New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin… (NCT00035854) | Clinical Trial Compass
CompletedPhase 3
New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)
United States13 participantsStarted 2002-02
Plain-language summary
This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
Who can participate
Age range17 Years
SexALL
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Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.
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
What they're measuring
1
Investigator's and sponsor's evaluation of patient clinical outcome.