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

Condition(s) targeted: Bacterial Infections

Intervention: Zyvox® / Linezolid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

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

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

Study design: Treatment, Randomized, Open Label, Single Group Assignment

Primary outcome: Investigator’s and sponsor’s evaluation of patient clinical outcome.

Secondary outcome: Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Both.

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

Research Center, Los Angeles, California 90095, United States

Research Center, Los Angeles, California 90027, United States

Research Center, Long Beach, California 90806, United States

Research Center, Hartford, Connecticut 06106, United States

Research Center, Washington, District of Columbia 20010, United States

Research Center, Gainesville, Florida 32610, United States

Research Center, Gainesville, Florida 32610, United States

Research Center, Atlanta, Georgia 30342, United States

Research Center, Park Ridge, Illinois 60068, United States

Research Center, Chicago, Illinois 60614, 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 10029, United States

Research Center, New York, New York 10032, United States

Research Center, New York, New York 10021, United States

Research Center, Cleveland, Ohio 44195, United States

Research Center, Philadelphia, Pennsylvania 19104, United States

Research Center, Danville, Pennsylvania 17822, United States

Research Center, Austin, Texas 78701, United States

Link to ClinicalStudyResults.org Posting

Starting date: February 2002
Ending date: May 2004
Last updated: July 2, 2007