TRIAL OF ANTIBIOTICS TO REDUCE RECURRENT TRICHIASIS

抗生素减少倒睫复发的试验

• 批准号: 6805320
• 负责人: SHEILA K WEST
• 金额: $ 71.54万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6805320
• 关键词: Chlamydia trachomatis; chemoprevention; clinical research; clinical trials; cooperative study; disease /disorder prevention /control; drug administration routes; drug screening /evaluation; eye disorder diagnosis; eye surgery; family therapy; human subject; human therapy evaluation; longitudinal human study; medical complication; oral administration; patient oriented research; polymerase chain reaction; postoperative state; relapse /recurrence; tetracyclines; topical drug application; trachomas

Trachoma, caused by C. trachomatis, is the second leading cause of blindness worldwide, and control is a top priority of the blindness prevention community. In trachoma-endemic areas, 10% or more of adults have trichiasis, resulting from years of repeated infection, which is high risk for subsequent visual loss. Trichiasis can be corrected with surgery, but the recurrence rate at one year is disappointingly high, 17%, and it increases in subsequent years. There is strong evidence that ongoing exposure to infection with C. trachomatis, either from a persistent injection or exposure within families, drives ongoing scarring and trichiasis in these cases. The primary questions to be addressed by this investigation are: 1) Does post-surgical treatment of trichiasis cases with azithromycin reduce the one-year recurrence rate of trichiasis compared to standard care (topical tetracycline)? 2) Does post-surgical treatment of cases plus household members with azithromycin reduce the one-year recurrence rate of trichiasis compared to standard treatment? We propose a randomized, controlled clinical trial of 1425 adults with trichiasis scheduled for surgery in two health centers in the Lanfuro district of Ethiopia to address this questions. The three arm trial will have one arm in which cases receive a single dose of azithromycin post- surgery; a third arm in which cases will receive topical tetracycline post- surgery. Data on other risk factors will include baseline severity of trichiasis, surgery-related factors, and laboratory evidence and re- infection. Cases will be examined at 2 weeks and 2, 6, and 12 months post-surgery for recurrence of trichiasis. The results of this trial will have immediate public health impact by providing information for WHO recommendations for post-surgical treatment of trichiasis, as well as by guiding policy on azithromycin use for the 22 countries beginning National Trachoma Control programs worldwide.

沙丘瘤是由梭状芽孢杆菌引起的，是全球失明的第二大主要原因，控制是盲目预防社区的重中之重。在沙眼流行区域，由于多年的反复感染导致了10％或更多的成年人患有三十症，这是随后的视觉丧失的高风险。可以通过手术来纠正滴虫病，但是一年的复发率令人失望地高17％，随后的几年增加。有强有力的证据表明，在这些情况下，持续接触沙眼的感染，无论是持续的注射或暴露，都可以在这些情况下驱动持续的疤痕和毛状病毒。这项调查要解决的主要问题是：1）与标准护理（局部四环素）相比，对阿奇霉素的三静脉病例的手术后治疗是否会降低三脑疾病的复发率？ 2）与标准治疗相比，手术后的病例治疗加上阿奇霉素的家庭成员是否降低了一年的呈三思症的复发率？我们提出了一项随机对照的临床试验，该试验计划在埃塞俄比亚Lanfuro区的两个卫生中心进行手术，以解决此问题。三臂试验将有一只臂，其中手术后接受一剂阿奇霉素。第三臂将接受手术后进行局部四环素。有关其他危险因素的数据将包括刻板病的基线严重程度，与手术有关的因素以及实验室证据和感染。在手术后2周，2周，6个和12个月复发的三思症时，将检查病例。这项试验的结果将立即对公共卫生的影响，通过为WHO提供有关三静脉后手术后治疗的建议，以及指导对全球全国性的全国性气管控制计划的22个国家使用的阿奇罗霉素使用政策。