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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.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00035854
First received: May 6, 2002
Last updated: August 13, 2009
Last verified: August 2009

May 6, 2002
August 13, 2009
February 2002
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Investigator's and sponsor's evaluation of patient clinical outcome.
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Complete list of historical versions of study NCT00035854 on ClinicalTrials.gov Archive Site
Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).
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New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)
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)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bacterial Infections
Drug: Zyvox® / Linezolid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
May 2004
Not Provided

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
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035854
M12600082VRE, A5951062
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Pfizer
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Not Provided
Pfizer
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP