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

Bacterial Infections Clinical Trial

Official title:

Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035854
• Other study ID #: M12600082VRE
• Secondary ID: A5951062
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2002
• Last updated: August 13, 2009
• Start date: February 2002
• Est. completion date: May 2004

Study information

• Verified date: August 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Infection

Intervention

Drug:
• Zyvox® / Linezolid

Locations

Country	Name	City	State
United States	Research Center	Atlanta	Georgia
United States	Research Center	Austin	Texas
United States	Research Center	Baltimore	Maryland
United States	Research Center	Boston	Massachusetts
United States	Research Center	Camden	New Jersey
United States	Research Center	Chicago	Illinois
United States	Research Center	Cleveland	Ohio
United States	Research Center	Danville	Pennsylvania
United States	Research Center	Detroit	Michigan
United States	Research Center	Gainesville	Florida
United States	Research Center	Hartford	Connecticut
United States	Research Center	Long Beach	California
United States	Research Center	Los Angeles	California
United States	Research Center	Los Angeles	California
United States	Research Center	Louisville	Kentucky
United States	Research Center	New York	New York
United States	Research Center	New York	New York
United States	Research Center	New York	New York
United States	Research Center	Park Ridge	Illinois
United States	Research Center	Philadelphia	Pennsylvania
United States	Research Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's and sponsor's evaluation of patient clinical outcome.
Secondary	Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).