Clinical trial NCT00035854: New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)
Official title: Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Keywords: Pharmacia
Drug Resistance, Microbial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-07
Enrollment: 13
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Investigator's and sponsor's evaluation of patient clinical outcome.
Secondary outcomes:
measure: Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Research Center
state: California
city: Los Angeles
country: United States
facility: Research Center
state: California
city: Los Angeles
country: United States
facility: Research Center
state: California
city: Hartford
country: United States
facility: Research Center
state: Connecticut
city: Washington
country: United States
facility: Research Center
state: District of Columbia
city: Gainesville
country: United States
facility: Research Center
state: Florida
city: Atlanta
country: United States
facility: Research Center
state: Georgia
city: Chicago
country: United States
facility: Research Center
state: Illinois
city: Park Ridge
country: United States
facility: Research Center
state: Illinois
city: Louisville
country: United States
facility: Research Center
state: Kentucky
city: Baltimore
country: United States
facility: Research Center
state: Maryland
city: Boston
country: United States
facility: Research Center
state: Massachusetts
city: Detroit
country: United States
facility: Research Center
state: Michigan
city: Camden
country: United States
facility: Research Center
state: New Jersey
city: New York
country: United States
facility: Research Center
state: New York
city: New York
country: United States
facility: Research Center
state: New York
city: New York
country: United States
facility: Research Center
state: New York
city: Cleveland
country: United States
facility: Research Center
state: Ohio
city: Danville
country: United States
facility: Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Center
state: Pennsylvania
city: Austin
country: United States
facility: Research Center
state: Texas
Study officials:
References: