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

This study has been completed.

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

MedlinePlus related topics:   Antibiotics    Bacterial Infections   

ChemIDplus related topics:   Vancomycin    Linezolid    Vancomycin hydrochloride   

U.S. FDA Resources

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

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

Show 22 study locations  Show 22 Study Locations

Sponsors and Collaborators
Pfizer
  More Information

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

Study ID Numbers:   M/1260/0082-VRE, A5951062
First Received:   May 6, 2002
Last Updated:   July 2, 2007
ClinicalTrials.gov Identifier:   NCT00035854
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
Vancomycin
Linezolid

Additional relevant MeSH terms:
Protein Synthesis Inhibitors
Anti-Infective Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008




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