inezolid for the Treatment of Suspected or Proven Gram-positive Infections: A Randomized, Open-label Trial Comparing Linezolid IV/PO and Teicoplanin IV or IM.
- Conditions
- -J18-L03-I38 Endocarditis, valve unspecifiedEndocarditis, valve unspecifiedL03I38J18
- Registration Number
- PER-009-00
- Lead Sponsor
- PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
•Males or female subjects must be at least 13 years of age and weigh at least 40 kg.
•At the time of enrollment, patients must be expected to survive with effective antibiotic therapy and appropriate supportive care throughout the study.
•Patients must be willing to complete all study-related activities.
•Patients must have a known or suspected Gram-positive infection for which treatment with a glycopeptide would be clinically indicated.
•For the following clinical syndromes patients must also have signs and symptoms of an active infection: pneumonia, skin and soft tissue infection, right sided endocarditis, known or suspected gram-positive bacteremia.
•Females of childbearing potential must not be breastfeeding and must have a negative pregnancy test at baseline before taking any study medication, and must practice 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.
•Left-sided endocarditis, osteomyelitis, and CNS infections.
•Patients with infected devices in which the device will not be removed.
•Known pheochromocytoma, carcinoid syndrome, untreated hyperthyroidism, or uncontrolled hypertension.
•Previous enrollment in this protocol or another linezolid protocol.
•Hypersensitivity to linezolid, vancomycin, teicoplanin or one of the excipients in any of these drug formulations
•Patients whose baseline laboratory assay results are known to exceed the following criteria are ineligible for study entry:
absolute neutrophil count < 500/mm
known liver disease with total bilirubin > 5.0 x ULN
Note: Patients may receive the first 24 hours of therapy before obtaining the results of these assays.
•More than 24 hours of treatment with a potentially effective antibiotic within 48 hours of study entry, unless the therapy failed. See Section 7.7 Prior and Concomitant Therapy for other permitted treatments.
•Note: Patients with right-sided endocarditis may be allowed 3 days of dosing with a potentially effective combination of antibiotics prior to enrollment in the study.
•Patients with infective exacerbations of COPD.
•Concurrent use of another investigational medication.
•Patients with infections that are anticipated to require more than 28 days of treatment.
•HIV positive patients who require prophylaxis for P. carinii
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:•Cured: Resolution of clinical signs and symptoms of Gram-positive infection, when compared with baseline (e.g., body temperature, WBC count). Improvement or lack of progression of infection-related radiographic abnormalities.<br>•Improved: Improvement in two or more, but not all, of clinical signs and symptoms of Grampositive infection, when compared with baseline. Improvement or lack of progression of infection-related radiographic abnormalities. This outcome category will only be used at the EOT evaluation.<br>•Failed: Persistence or progression of baseline clinical signs and symptoms of Gram-positive infection; progression of baseline infection-related radiographic abnormalities; development of new clinical findings consistent with active infection.<br>•Indeterminate. Extenuating circumstances preclude classification to one of the above.<br><br>Measure:Efficacy<br>Timepoints:Days 3,5 and 9; and every 6 days post-therapy<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:An acceptable risk-to-benefit ratio of linezolid in the treatment of Gram-positive infections is based on clinical and laboratory assessments planned to detect adverse drug reactions. Throughout the treatment and post-treatment period, changes in physical findings, clinical signs and symptoms, and laboratory values that may reflect adverse effects will be documented. In addition, any adverse events volunteered by the patient will be recorded. All adverse events must be entered on the case report form.<br>Measure:Safety<br>Timepoints:Throughout the treatment and post-treatment period<br>