A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.

U.S. Bioscience1 个研究点分布在 1 个国家开始时间: 2001年8月31日最近更新: 2005年6月24日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

To provide trimetrexate glucuronate to immunosuppressed patients with Pneumocystis carinii pneumonia (PCP) for whom this investigational compound could provide significant medical benefit.

详细描述

Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate.

研究设计

研究类型: Interventional
主要目的: Treatment
盲法: None

入排标准

年龄范围: 1 Day 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Concurrent Medication:
•Antiretroviral therapy (at the discretion of the treating physician and/or medical monitor).
•Patients must have:
•Presumptive or definitive diagnosis of Pneumocystis carinii pneumonia (PCP).
•HIV positivity or be otherwise immunosuppressed.
•Demonstrated intolerance and/or resistance to trimethoprim/sulfamethoxazole during the course of therapy for the current episode and not candidates for parenteral pentamidine, OR a documented history of such intolerance during a prior episode.
•Consent of parent or guardian if less than 18 years of age.
•In general, patients who meet the eligibility criteria for other U.S. Bioscience-sponsored clinical trials for trimetrexate would not be eligible for this Compassionate Use protocol.

排除标准

•Patients with the following prior conditions are excluded:
•History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions to trimetrexate.

研究者

发起方

U.S. Bioscience

申办方类型

Industry

研究点 (1)

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