NCT00001123已完成不适用
A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome
National Institute of Allergy and Infectious Diseases (NIAID)2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 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
- 入组人数
- 130
- 试验地点
- 2
研究概览
简要总结
The purpose is to test the safety and effectiveness of intravenous ribavirin therapy in persons with suspected and subsequently proven hantavirus infection. The hantavirus is spread through the air into the lungs when dry rodent feces are moved or disturbed. It is characterized by fever and bleeding.
详细描述
Patients are randomized to receive either ribavirin or a placebo for 7 days. At the completion of therapy, patients will be seen on follow-up visits on days 14, 28, and 84.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You may be eligible for this study if you:
- •Are 12 years of age or older.
- •Are not pregnant.
- •Agree to practice sexual abstinence or use accepted barrier methods of birth control/contraception.
- •Are not breast-feeding.
- •Have a positive blood test for hantavirus.
- •Have symptoms suggestive of hantavirus illness.
排除标准
- •You will not be eligible for this study if you:
- •Have severe low blood count (anemia).
- •Have a diagnosis of other respiratory viruses (influenza, RSV, etc.).
- •Have group A Streptococcus with symptoms of streptococcal pharyngitis, a positive culture from a normally sterile site, or symptoms of bacterial pneumonia.
- •Are HIV positive.
- •Have cancer.
- •Have had any period of irregular heartbeat.
- •Have had chemotherapy or other drugs that suppress the immune system within 30 days.
- •Have taken by mouth or injection any antiviral drug (other than acyclovir, famciclovir, amantadine or rimantadine.)
- •Have taken by mouth or injection corticosteroids equivalent to approximately 0.5 mg/kg prednisone.
- •Have taken any experimental drug within 30 days prior to enrollment.
研究者
研究点 (2)
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