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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00035854

Purpose

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

Condition	Intervention	Phase
Bacterial Infections	Drug: Zyvox® / Linezolid	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment
Official Title:	Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Bacterial Infections

Drug Information available for: Linezolid Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	13
Study Start Date:	February 2002
Study Completion Date:	May 2004

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035854

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Locations

United States, California
Research Center
Los Angeles, California, United States, 90095
Research Center
Los Angeles, California, United States, 90027
Research Center
Long Beach, California, United States, 90806
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
Research Center
Gainesville, Florida, United States, 32610
United States, Georgia
Research Center
Atlanta, Georgia, United States, 30342
United States, Illinois
Research Center
Park Ridge, Illinois, United States, 60068
Research Center
Chicago, Illinois, United States, 60614
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, 10029
Research Center
New York, New York, United States, 10032
Research Center
New York, New York, United States, 10021
United States, Ohio
Research Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Research Center
Philadelphia, Pennsylvania, United States, 19104
Research Center
Danville, Pennsylvania, United States, 17822
United States, Texas
Research Center
Austin, Texas, United States, 78701

Sponsors and Collaborators

Pfizer

More Information

Additional Information:

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	M12600082VRE, A5951062
Study First Received:	May 6, 2002
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00035854 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pharmacia
Drug Resistance, Microbial

Additional relevant MeSH terms:

Bacterial Infections
Protein Synthesis Inhibitors
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Vancomycin
Enzyme Inhibitors
Infection
Linezolid
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009