NCT00002434已完成不适用
A Study of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia
U.S. Bioscience2 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:
适应症
相关药物
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
简要总结
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine).
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. Patients are followed for 1 month.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Myelosuppressive or nephrotoxic agents at the discretion of the treating physician.
- •Patients must have:
- •Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry.
- •Serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of PCP, or a documented history of such intolerance during a prior episode.
- •Consent of parent or guardian if less than 18 years of age.
- •Pregnant women may enroll after the physician and patient have discussed the potential benefit versus risk.
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 due to trimetrexate glucuronate.
研究者
研究点 (2)
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