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
2 other identifiers
interventional
13
1 country
21
Brief Summary
This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2002
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 6, 2002
CompletedFirst Posted
Study publicly available on registry
May 7, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedAugust 14, 2009
August 1, 2009
May 6, 2002
August 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigator's and sponsor's evaluation of patient clinical outcome.
Secondary Outcomes (1)
Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).
Interventions
Eligibility Criteria
You may not 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.
- 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
- hours of antibiotic treatment within 48 hours of study entry (unless pre-approved)
- Having an infected device that could not be removed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (21)
Research Center
Long Beach, California, 90806, United States
Research Center
Los Angeles, California, 90027, United States
Research Center
Los Angeles, California, 90095, United States
Research Center
Hartford, Connecticut, 06106, United States
Research Center
Washington D.C., District of Columbia, 20010, United States
Research Center
Gainesville, Florida, 32610, United States
Research Center
Atlanta, Georgia, 30342, United States
Research Center
Chicago, Illinois, 60614, United States
Research Center
Park Ridge, Illinois, 60068, United States
Research Center
Louisville, Kentucky, 40202, United States
Research Center
Baltimore, Maryland, 21287, United States
Research Center
Boston, Massachusetts, 02111, United States
Research Center
Detroit, Michigan, 48201, United States
Research Center
Camden, New Jersey, 08103, United States
Research Center
New York, New York, 10021, United States
Research Center
New York, New York, 10029, United States
Research Center
New York, New York, 10032, United States
Research Center
Cleveland, Ohio, 44195, United States
Research Center
Danville, Pennsylvania, 17822, United States
Research Center
Philadelphia, Pennsylvania, 19104, United States
Research Center
Austin, Texas, 78701, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 6, 2002
First Posted
May 7, 2002
Study Start
February 1, 2002
Study Completion
May 1, 2004
Last Updated
August 14, 2009
Record last verified: 2009-08