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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00035854

Collaborator

(none)

Enrollment

Locations

26.9

Duration (Months)

0.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections	Drug: Zyvox® / Linezolid	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2002

Actual Study Completion Date :

May 1, 2004

Outcome Measures

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). []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Research Center	Long Beach	California	United States	90806
2	Research Center	Los Angeles	California	United States	90027
3	Research Center	Los Angeles	California	United States	90095
4	Research Center	Hartford	Connecticut	United States	06106
5	Research Center	Washington	District of Columbia	United States	20010
6	Research Center	Gainesville	Florida	United States	32610
7	Research Center	Atlanta	Georgia	United States	30342
8	Research Center	Chicago	Illinois	United States	60614
9	Research Center	Park Ridge	Illinois	United States	60068
10	Research Center	Louisville	Kentucky	United States	40202
11	Research Center	Baltimore	Maryland	United States	21287
12	Research Center	Boston	Massachusetts	United States	02111
13	Research Center	Detroit	Michigan	United States	48201
14	Research Center	Camden	New Jersey	United States	08103
15	Research Center	New York	New York	United States	10021
16	Research Center	New York	New York	United States	10029
17	Research Center	New York	New York	United States	10032
18	Research Center	Cleveland	Ohio	United States	44195
19	Research Center	Danville	Pennsylvania	United States	17822
20	Research Center	Philadelphia	Pennsylvania	United States	19104
21	Research Center	Austin	Texas	United States	78701