NCT00004278已完成3 期
Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection
National Center for Research Resources (NCRR)0 个研究点目标入组 130 人开始时间: 1991年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
研究概览
简要总结
OBJECTIVES:
I. Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease.
详细描述
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12 hours for 6 weeks.
Patients are followed at weeks 1-4 and 12, months 6, 12, 24, 36, 48, and 60, and yearly thereafter until puberty (when possible).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 0 Years 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Symptomatic cytomegalovirus (CMV) infection: Central nervous system disease, with or without other organ system involvement, e.g.: Microcephaly, i.e., less than 5% for age Radiologic changes indicating brain disease Cerebrospinal fluid exam abnormal for age Chorioretinitis Hearing defects
- •CMV confirmed by urine, throat, buffy coat, and/or conjunctiva culture
- •No hydroencephalopathy or other devastating brain involvement
- •-Prior/Concurrent Therapy--
- •No concurrent antiviral agent No concurrent immune globulin
- •-Patient Characteristics--
- •Age: Under 1 month (preferably under 2 weeks)
- •Life expectancy: No imminent demise
- •Renal: Creatinine no greater than 1.5 mg/dL
- •Other: Birth weight at least 1200 g Gestational age at least 32 weeks No HIV infection No concurrent bacterial infection Eligible if resolved following 2-week treatment and CMV symptoms persist
排除标准
- 未提供
研究者
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