Bacterial Infections
Conditions
Keywords
Pharmacia, Drug Resistance, Microbial
Brief summary
This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
Interventions
DRUGZyvox® / Linezolid
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator's and sponsor's evaluation of patient clinical outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP). | — |
Countries
United States
Outcome results
None listed