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

August 13, 2009 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Research Center
      • Los Angeles, California, United States, 90095
        • Research Center
      • Los Angeles, California, United States, 90027
        • Research Center
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Research Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Research Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Research Center
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Research Center
      • Park Ridge, Illinois, United States, 60068
        • Research Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Research Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Research Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Research Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Research Center
    • New York
      • New York, New York, United States, 10021
        • Research Center
      • New York, New York, United States, 10029
        • Research Center
      • New York, New York, United States, 10032
        • Research Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Research Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Center
    • Texas
      • Austin, Texas, United States, 78701
        • Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Investigator's and sponsor's evaluation of patient clinical outcome.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

May 6, 2002

First Submitted That Met QC Criteria

May 6, 2002

First Posted (Estimate)

May 7, 2002

Study Record Updates

Last Update Posted (Estimate)

August 14, 2009

Last Update Submitted That Met QC Criteria

August 13, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12600082VRE
  • A5951062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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