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
  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 3

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 21 Study Locations
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

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

Keywords provided by Pfizer:
Pharmacia
Drug Resistance, Microbial

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

ClinicalTrials.gov processed this record on October 29, 2014