GANCICLOVIR (DHPG) FOR SYMPTOMATIC CONGENITAL CYTOMEGALOVIRUS INFECTIONS

更昔洛韦 (DHPG) 治疗有症状的先天性巨细胞病毒感染

• 批准号: 6274080
• 负责人: RICHARD J. WHITLEY
• 金额: $ 2.59万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-01-26 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274080
• 关键词: Herpesviridae disease; acute disease /disorder; central nervous system disorders; child (0-11); clinical research; congenital infection; cytomegalovirus; ganciclovir; growth /development; hearing; human subject; human therapy evaluation; infant human (0-1 year); microorganism disease chemotherapy; outcomes research; virus load; vision

This protocol will study congenital cytomegalovirus infection in infants with symptomatic central nervous system involvement. In patients who are randomized to the treatment arm, hospitalization will be for the duration of the treatment phase. The treatment phase will be a minimum of 42 days and will involve close clinical monitoring as well as frequent laboratory studies. CBC#4, reticulocyte counts, renal/liver function studies and urinalysis will be done 12 times each as well as other tests to monitor potential drug toxicities. Baseline assessments include CAT scan of head, audiological, brain stem evoked response and Denver Developmental Assesment. The use of the GCRC makes possible evaluation of potential benefits/risks of the use of DHPG in the treatment of congenital CMV infection in this extremely complicated protocol. Non-treated patients will be seen weekly for seven weeks. In addition to laboratory specimens collected at each weekly visit, long-term follow-up for both arms of the study include appropriate audiological asessments, opthalmalogic assessments and developmental assessments through at lease the child's fifth year.

该方案将研究婴儿先天性巨细胞病毒感染 有症状的中枢神经系统受累。 在以下患者中 随机分配到治疗组，住院期间将持续 的治疗阶段。 治疗阶段至少为 42 天 并将涉及密切的临床监测以及频繁的实验室检查 研究。 CBC#4、网织红细胞计数、肾/肝功能研究和 尿液分析各进行 12 次，并进行其他监测测试 潜在的药物毒性。 基线评估包括头部 CAT 扫描、 听力学、脑干诱发反应和丹佛发育 评估。 GCRC 的使用使得评估潜力成为可能 使用 DHPG 治疗先天性 CMV 的益处/风险 在这个极其复杂的协议中感染。未接受治疗的患者 将每周见一次，持续七周。 除了实验室标本 每周访视收集，对双臂进行长期随访 研究包括适当的听力学评估、眼科评估 至少通过孩子的评估和发展评估 第五年。