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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:
ClinicalTrials.gov Identifier:
NCT00035854
First Posted: May 7, 2002
Last Update Posted: August 14, 2009
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.
Information provided by:
Pfizer
May 6, 2002
May 7, 2002
August 14, 2009
February 2002
Not Provided
Investigator's and sponsor's evaluation of patient clinical outcome.
Not Provided
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: None (Open Label)
Primary Purpose: Treatment
Bacterial Infections
Drug: Zyvox® / Linezolid
Not Provided
Not Provided

*   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
Sexes Eligible for Study: All
up to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00035854
M12600082VRE
A5951062
Not Provided
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Pfizer
Not Provided
Not Provided
Pfizer
August 2009

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