None listed
Conditions
Interventions
Group 1 linezolid, Group 2: Vancomycin and Group 3: Vancomycin plus linezolid Type of group
Group 1: Linezolid 600 mg every 12 hours IV or PO. Group 2: Vancomycin 1 g every 12 hours IV (dose may be adjusted by
blood level determination to maintain therapeutic troughs). Group 3: Vancomycin IV followed by a switch to linezolid PO
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or female subjects must be at least 13 years of age and weigh at least 40 kg. 2. At the time of enrollment, patients must be expected to survive with effective antibiotic therapy and appropriate supportive care throughout the study. 3. Patients must be willing to complete all study-related activities. 4. Patients must have a positive culture for MRSA from an infected site or be a known carrier of MRSA as determined by prior positive cultures and have signs and symptoms of an active infection as outlined below for the following clinical syndromes.
Exclusion criteria
Exclusion criteria: 1. Females of childbearing potential must not be breastfeeding and must have a negativo pregnancy test at baseline before taking any study medication, and must practico adequate methods of birth control to prevent pregnancy during the study. Since linezolid is not a substrato for, or an inhibitor of, the human cytochrome P-450 enzymes, hormonal contraception is permitted, as no drug-drug interaction is expected. 2. Left-sided endocarditis, osteomyelitis, and CNS infections. 3. Patients with infected devices in whom the device will not be removed. 4. Known pheochromocytoma. carcinoid syndrome, untreated hyperthyroidism, or uncontrolled hypertension. 5. Previous enrollment in this protocol or another linezolid protocol. 6. Hypersensitivity to linezolid or vancomycin or one of the excipients in either drug formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary efficacy variables in this study are patient clinical outcomes, microbiologic outcomes, and overall (combined clinical/microbiologic) outcomes. The primary comparisons of interest are linezolid vs vancomycin and the combination vs. vancomycin. The test-of- cure assessments will be those done at ihe designated visits (and will be considered the primary time point of interest). Patients classified as failures will be carried forward ffom EOT to STFU if no STFU data are available. Measure:Patients classified as failures will be carried forward ffom EOT to STFU if no STFU data are available Timepoints:Before a clinical assessment of failure can be made, patients must be treated for at least 2 days (4 doses). Before a clinical assessment of success can be madc, patients must be treated for at least 5 days (10 doses). | — |
Countries
Germany, Peru, United States
Outcome results
None listed