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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00035854
Recruitment Status : Completed
First Posted : May 7, 2002
Last Update Posted : August 14, 2009
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Bacterial Infections Drug: Zyvox® / Linezolid Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children
Study Start Date : February 2002
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid




Primary Outcome Measures :
  1. Investigator's and sponsor's evaluation of patient clinical outcome.

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035854


Locations
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United States, California
Research Center
Long Beach, California, United States, 90806
Research Center
Los Angeles, California, United States, 90027
Research Center
Los Angeles, California, United States, 90095
United States, Connecticut
Research Center
Hartford, Connecticut, United States, 06106
United States, District of Columbia
Research Center
Washington, District of Columbia, United States, 20010
United States, Florida
Research Center
Gainesville, Florida, United States, 32610
United States, Georgia
Research Center
Atlanta, Georgia, United States, 30342
United States, Illinois
Research Center
Chicago, Illinois, United States, 60614
Research Center
Park Ridge, Illinois, United States, 60068
United States, Kentucky
Research Center
Louisville, Kentucky, United States, 40202
United States, Maryland
Research Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Research Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Research Center
Detroit, Michigan, United States, 48201
United States, New Jersey
Research Center
Camden, New Jersey, United States, 08103
United States, New York
Research Center
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
United States, Ohio
Research Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Research Center
Danville, Pennsylvania, United States, 17822
Research Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Research Center
Austin, Texas, United States, 78701
Sponsors and Collaborators
Pfizer
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ClinicalTrials.gov Identifier: NCT00035854    
Other Study ID Numbers: M12600082VRE
A5951062
First Posted: May 7, 2002    Key Record Dates
Last Update Posted: August 14, 2009
Last Verified: August 2009
Keywords provided by Pfizer:
Pharmacia
Drug Resistance, Microbial
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action