Melese Muluken, Alemayehu Wondu, Lakew Takele, Yi Elizabeth, House Jenafir, Chidambaram Jaya D, Zhou Zhaoxia, Cevallos Vicky, Ray Kathryn, Hong Kevin Cyrus, Porco Travis C, Phan Isabella, Zaidi Ali, Gaynor Bruce D, Whitcher John P, Lietman Thomas M
Orbis International, Addis Ababa, Ethiopia.
JAMA. 2008 Feb 20;299(7):778-84. doi: 10.1001/jama.299.7.778.
Treatment recommendations assume that repeated mass antibiotic distributions can control, but not eradicate or even locally eliminate, the ocular strains of chlamydia that cause trachoma. Elimination may be an important end point because of concern that infection will return to communities that have lost immunity to chlamydia after antibiotics are discontinued.
To determine whether biannual treatment can eliminate ocular chlamydial infection from preschool children and to compare results with the World Health Organization-recommended annual treatment.
DESIGN, SETTING, AND PARTICIPANTS: A cluster-randomized clinical trial of biannual vs annual mass azithromycin administrations to all residents of 16 rural villages in the Gurage Zone, Ethiopia, from March 2003 to April 2005.
At scheduled treatments, all individuals aged 1 year or older were offered a single dose of oral azithromycin either annually or biannually.
Village prevalence of ocular chlamydial infection and presence of elimination at 24 months in preschool children determined by polymerase chain reaction, correcting for baseline prevalence. Antibiotic treatments were performed after sample collections.
Overall, 14,897 of 16,403 eligible individuals (90.8%) received their scheduled treatment. In the villages in which residents were treated annually, the prevalence of infection in preschool children was reduced from a mean of 42.6% (range, 14.7%-56.4%) to 6.8% (range, 0.0%-22.0%) at 24 months. In the villages in which residents were treated biannually, infection was reduced from 31.6% pretreatment (range, 6.1%-48.6%) to 0.9% (range, 0.0%-4.8%) at 24 months. Biannual treatment was associated with a lower prevalence at 24 months (P = .03, adjusting for baseline prevalence). At 24 months, no infection could be identified in 6 of 8 of those treated biannually and in 1 of 8 of those treated annually (P = .049, adjusting for baseline prevalence).
Local elimination of ocular chlamydial infection appears feasible even in the most severely affected areas, although it may require biannual mass antibiotic distributions at a high coverage level.
clinicaltrials.gov Identifier: NCT00221364.
治疗建议认为，反复进行大规模抗生素分发可控制但无法根除甚至无法在局部消除导致沙眼的眼部衣原体菌株。由于担心在停用抗生素后对衣原体失去免疫力的社区感染会复发，消除感染可能是一个重要的终点。
确定每半年进行一次治疗是否能消除学龄前儿童眼部衣原体感染，并将结果与世界卫生组织推荐的每年治疗进行比较。
设计、地点和参与者：2003年3月至2005年4月，在埃塞俄比亚古拉格地区16个乡村对所有居民进行每半年与每年一次大规模阿奇霉素给药的整群随机临床试验。
在预定治疗时，每年或每半年为所有1岁及以上个体提供一剂口服阿奇霉素。
通过聚合酶链反应确定学龄前儿童眼部衣原体感染的村庄患病率以及24个月时消除感染的情况，并校正基线患病率。样本采集后进行抗生素治疗。
总体而言，16403名符合条件的个体中有14897名（90.8%）接受了预定治疗。在居民每年接受治疗的村庄，学龄前儿童的感染患病率在24个月时从平均42.6%（范围14.7%-56.4%）降至6.8%（范围0.0%-22.0%）。在居民每半年接受治疗的村庄，感染率从治疗前的31.6%（范围6.1%-48.6%）降至24个月时的0.9%（范围0.0%-4.8%）。每半年治疗与24个月时较低的患病率相关（P = 0.03，校正基线患病率）。在24个月时，每半年接受治疗的8个村庄中有6个未发现感染，每年接受治疗的8个村庄中有1个未发现感染（P = 0.049，校正基线患病率）。
即使在受影响最严重的地区，局部消除眼部衣原体感染似乎也是可行的，尽管这可能需要在高覆盖率水平下每半年进行一次大规模抗生素分发。
clinicaltrials.gov标识符：NCT00221364。
