PER-018-99已完成未知
INEZOLID FOR THE TREATMENT OF INFECTIONS FOR CHECKED OR PRESENTED GRAM INFECTIONS: AN OPEN RANDOMIZED TEST THAT COMPARES LINEZOLID BY INTRAVENOUS ORAL ROUTE WITH INTRAVENOUS OR INTRAMUSCULAR VIA
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,0 个研究点目标入组 0 人开始时间: 1999年11月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male or female individuals must be at least 13 years old and weigh at least 40 kg.
- •At the time of incorporation into the study, patients are expected to survive the entire study, with effective antibiotic therapy and with appropriate care.
- •Patients should be willing to complete all activities related to the study.
- •Patients must have a known or suspected Gram positive infection, for which a treatment with a glycopeptide is clinically indicated.
排除标准
- •Female patients of childbearing age should not be breastfeeding, should have a negative baseline pregnancy test before taking any of the medications in the study, and practice proper pregnancy prevention methods to avoid becoming pregnant during pregnancy. study. Since linezolid is neither a substrate nor an inhibitor of human cytochrome P-450 enzymes, hormonal contraception is allowed, since no drug-drug interaction is expected.
- •Endocarditis of the left cavities, osteomyelitis and infections of the central nervous system.
- •Patients with infected devices that will not be removed.
- •Pheochromocytoma, carcinoid syndrome, untreated hyperthyroidism or uncontrolled hypertension, known.
- •Previous incorporation into this protocol or another linezolid protocol.
- •Hypersensitivity to linezolid, vancomycin, teicoplanin or one of the excipients of any of said drug formulations
- •Patients whose results from baseline laboratory tests are known to exceed the following criteria, will be ineligible for incorporation into the study: absolute neutrophil count <500 / mm ^ 3, known liver disease with a total bilirubin> 5, 0 x Upper Level Normal.
- •More than 24 hours of treatment with a potentially effective antibiotic within 48 hours prior to incorporation into the study, unless the therapy has failed. For more information on allowed treatments see Section 7.7 Prior and Concomitant Therapy.
- •Patients with infectious exacerbations of COPD.
- •Concomitant use of other medication under investigation.
- •Patients with anticipated infections require more than 28 days of treatment.
- •HIV positive patients who require P. carinii prophylaxis.
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