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

This study has been completed.

First Received: May 6, 2002 Last Updated: August 13, 2009 History of Changes

Sponsored by:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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).

Eligibility

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

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

Study placed in the following topic categories:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Vancomycin
Linezolid

Additional relevant MeSH terms:

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

Therapeutic Uses
Enzyme Inhibitors
Infection
Linezolid
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009