New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)
Phase 3
Completed
- Conditions
- Bacterial Infections
- Registration Number
- NCT00035854
- Lead Sponsor
- Pfizer
- Brief Summary
This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Investigator's and sponsor's evaluation of patient clinical outcome.
- Secondary Outcome Measures
Name Time Method Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).
Trial Locations
- Locations (1)
Research Center
🇺🇸Austin, Texas, United States