INEZOLID FOR THE TREATMENT OF METHICILIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTIONS: AN EVALUATOR-BLINDED TRIAL COMPARING LINEZOLID WITH VANCOMYCIN ALONE AND VANCOMYCIN FOLLOWED BY ORAL LINEZOLID

PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,0 个研究点目标入组 0 人开始时间: 1998年11月25日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•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.

•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

发起方

PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,