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

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Linezolid; Vancomycin

Criteria

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