A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia

Glaxo Wellcome2 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: 2

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 facilitate provision of atovaquone (566C80) to patients who have mild to moderate Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim / sulfamethoxazole (TMP / SMX ); to monitor serious adverse events attributable to 566C80.

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

•Patients must have the following:
•Clinical diagnosis of acute mild to moderate Pneumocystis carinii pneumonia.
•Dose-limiting intolerance to TMP / SMX or inadequate response to TMP / SMX.
•Willingness and ability to give informed consent. The clinical condition of the patient and appropriate physiologic criteria should be used in evaluating patients for therapy with 566C
•Patients who are rapidly progressing in disease severity or have severe disease as evidenced by sustained tachypnea (e.g., sustained respiratory rate > 30 breaths/minute), rapid deterioration in (A-a)DO2 and chest radiograph may not be appropriate candidates for oral therapy, including 566C
•Therapy with parenteral pentamidine should be undertaken in these cases. Treatment with IV trimetrexate or primaquine / clindamycin should be considered for these patients unless the patient is known to have dose-limiting intolerance to these agents. Patients with severe PCP who are intolerant and/or unresponsive to therapy with TMP / SMX and parenteral pentamidine may enroll in the 566C80 open-label compassionate plea protocol.

排除标准

•Patients with the following prior conditions are excluded: History of serious or dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug.

研究者

发起方

Glaxo Wellcome

申办方类型

Industry

研究点 (2)

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