Azithromycin in Control of Trachoma II

阿奇霉素控制沙眼 II

• 批准号: 6400005
• 负责人: JULIUS SCHACHTER
• 金额: $ 64.64万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-15 至 2006-05-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6400005
• 关键词: Chlamydia trachomatis; Egypt; azithromycin; blindness; clinical trials; disease /disorder prevention /control; eye disorder chemotherapy; field study; human subject; human therapy evaluation; longitudinal human study; mathematical model; microorganism disease chemotherapy; microorganism population study; oral administration; patient oriented research; trachomas

Trachoma is the world's leading cause of preventable blindness. This disease, caused by Chlamydia trachomatis, is endemic in many parts of the developing world. Several years ago in a project called Azithromycin in Control of Trachoma (ACT I) we evaluated the use of community-wide treatment with oral Azithromycin. This approach resulted in clinical improvement and dramatic reduction in prevalence of chlamydial infection through a 1- year follow-up. We now propose to return to these villages and do clinical surveys to assess trachoma activity, and to test conjunctival swabs for the presence of C. trachomatis by ligase chain reaction (LCR). The villages will include the previous treatment sites (oral) azithromycin versus topical tetracycline) as well 2 new villages that have not had any prior treatments. Thus we will determine the longterm (5 year) effects of the azithromycin, and follow them for 3 years. We will compare single-dose treatment with the 3 doses used in ACT I to determine the efficacy of this simpler, less expensive regime. All LCR positive specimens from the ACT I villages will have the major outer membrane gene amplified and sequenced. The genovars will be mapped for location within villages and families and then their distribution will be followed over time, after treatment to provide a better understanding of the epidemiology of the infection. Results of the study will be used as data input for the generation of mathematical model to predict whether community-wide retreatment (or alternate strategies) will be needed, and the optimal timing for such retreatment. In sum, this study should provide a rational approach to use of community-wide azithromycin treatment to eliminate blinding trachoma as a public health problem.

沙眼是世界上可预防的失明的主要原因。这种由沙眼衣原体引起的疾病在发展中国家的许多地区流行。几年前，在一个名为阿奇霉素控制沙眼的项目(ACT I)中，我们评估了口服阿奇霉素在社区范围内治疗的使用情况。通过一年的随访，这种方法导致了临床的改善和衣原体感染患病率的显著降低。我们现在建议回到这些村庄并进行临床调查，以评估沙眼的活动，并通过连接酶链式反应(LCR)检测结膜拭子中是否存在沙眼衣原体。这些村庄将包括以前的治疗地点(口服阿奇霉素与外用四环素)，以及2个以前没有接受过任何治疗的新村庄。因此，我们将确定阿奇霉素的长期(5年)疗效，并对其进行3年的跟踪观察。我们将单剂治疗与ACT I中使用的3剂进行比较，以确定这种更简单、更便宜的方案的疗效。所有来自ACT I村的LCR阳性标本都将进行主要外膜基因的扩增和测序。将绘制基因群在村庄和家庭中的位置图，然后在治疗后随着时间的推移跟踪它们的分布，以更好地了解感染的流行病学。研究结果将作为数据输入，用于建立数学模型，以预测是否需要在整个社区范围内进行再治疗(或替代策略)，以及进行这种再治疗的最佳时间。总之，这项研究应该提供一种合理的方法，使用全社区范围的阿奇霉素治疗，以消除作为公共卫生问题的致盲沙眼。