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

Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children

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

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