NCT00031473终止3 期
A Randomized Phase III Study to Evaluate the Safety and Efficacy of Ribavirin Inhaled Solution in Preventing Progression of Upper Respiratory Tract Respiratory Syncytial Virus Infection to RSV Pneumonia in Blood and Bone Marrow Transplant (BMT) Recipient
National Institute of Allergy and Infectious Diseases (NIAID)11 个研究点 分布在 1 个国家目标入组 90 人开始时间: 1997年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 90
- 试验地点
- 11
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of ribavirin, administered as an aerosol, in preventing progression of upper respiratory tract RSV infection to RSV pneumonia in bone marrow and peripheral blood transplant recipients.
详细描述
The study enrolls 90 transplant recipients with positive nasal/throat culture specimens for Respiratory Syncytial Virus (RSV) infection. Patients are randomized into one of two groups: investigational treatment or standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 5 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 years of age or older.
- •Are not pregnant or breast-feeding and agree to use a reliable birth control method for the duration of the study.
- •Are a blood or bone marrow transplant recipient.
- •Have evidence of upper respiratory tract infection.
- •Have nasopharyngeal-throat samples positive for RSV.
排除标准
- •Are known to be HIV positive.
- •Have pneumonia.
- •Require a ventilator to breathe.
- •Are pregnant.
- •Are breast-feeding and are unwilling to stop breast-feeding.
- •Are receiving treatment with certain other drugs for RSV.
研究者
研究点 (11)
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