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

Last updated: August 13, 2009
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Bacterial Infections

Treatment

N/A

Clinical Study ID

NCT00035854
M12600082VRE
A5951062
  • Ages < 17
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 diagnosisof 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 toenroll in the study. For most of the infections, 2 or more of additional symptoms arerequired.

Exclusion

Exclusion Criteria:

  • Potentially effective concomitant antibiotic

  • A high surgical cure rate

  • Medical conditions which would preclude clinical evaluation or require treatment oflonger 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

Total Participants: 13
Study Start date:
February 01, 2002
Estimated Completion Date:
May 31, 2004

Connect with a study center

  • Research Center

    Long Beach, California 90806
    United States

    Site Not Available

  • Research Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Research Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Research Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Research Center

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Research Center

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Research Center

    Chicago, Illinois 60614
    United States

    Site Not Available

  • Research Center

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Research Center

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Research Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Research Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Research Center

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Research Center

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Research Center

    New York, New York 10032
    United States

    Site Not Available

  • Research Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Research Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Research Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Research Center

    Austin, Texas 78701
    United States

    Site Not Available

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