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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Bacterial Infections

Treatments

Drug: Zyvox® / Linezolid

Study type

Interventional

Funder types

Industry

Identifiers

A5951062

M12600082VRE

Details and patient eligibility

About

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

Enrollment

13 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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