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.

Not Applicable

Completed

• Conditions: -J18-L03-I38 Endocarditis, valve unspecified; Endocarditis, valve unspecified; L03; I38; J18

• Registration Number: PER-009-00
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02-08
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•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.

Exclusion Criteria

•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