Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children
Data Collection
Bacterial Infections and Mycoses
+ Bacterial Infections
+ Infections
Treatment Study
Summary
Study start date: February 1, 2002
Actual date on which the first participant was enrolled.This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.13 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 21 locations
Research Center
Los Angeles, United StatesResearch Center
Los Angeles, United StatesResearch Center
Hartford, United States