PER-009-00已完成未知
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.
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,0 个研究点目标入组 0 人开始时间: 2000年2月8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
- •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.
排除标准
- •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
研究者
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