The impact of albendazole treatment on the incidence of viral- and bacterial-induced diarrhea in school children in southern Vietnam: study protocol for a randomized controlled trial.
The impact of albendazole treatment on the incidence of viral- and bacterial-induced diarrhea in school children in southern Vietnam: study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-016-1406-1
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发表时间：
2016-06-06
期刊：
影响因子：
2.5
通讯作者：
Baker S
中科院分区：
文献类型：
--
作者：
Leung JM;Hong CT;Trung NH;Thi HN;Minh CN;Thi TV;Hong DT;Man DN;Knowles SC;Wolbers M;Hoang Nle T;Thwaites G;Graham AL;Baker S
驱虫药是治疗人体肠道寄生蠕虫（尤其是线虫）感染的最常用药物之一。由于其成本效益，大规模的学校驱虫计划正在成为发展中国家的常规做法。然而，实验和临床证据表明，驱虫治疗可能会增加对细菌，病毒或原生动物引起的其他胃肠道感染的易感性。假设驱虫药可能会增加治疗儿童的尿道感染，我们的目的是评估驱虫药对越南南部学龄儿童由病毒和细菌病原体引起的尿道疾病发病率的影响。这是一项随机、双盲、安慰剂对照试验，旨在研究阿苯达唑治疗与安慰剂治疗对350名6-15岁的蠕虫感染和350名未感染蠕虫的越南学龄儿童中病毒和细菌诱导的腹泻发生率的影响。阿苯达唑或安慰剂治疗400 mg，每3个月给药一次，持续12个月。在12个月结束时，所有参与者将接受阿苯达唑治疗。本研究的主要终点是通过12个月每周主动和被动病例监测评估的乳腺炎发病率。次要终点包括蠕虫、病毒和细菌感染的患病率和强度，宿主免疫力和肠道微生物群与蠕虫和病原体清除的变化，体重指数平均z评分随时间的变化，以及不良事件的数量和严重程度。为了减少蠕虫负担，发展中国家的儿童经常服用驱虫药。然而，驱虫治疗对其他疾病（包括肠道病原体）易感性的影响仍不清楚。重要的是要监测药物治疗在合并感染人群中的意外后果。在这项试验中，我们将研究驱虫药治疗如何影响宿主对腹泻感染的易感性，目的是向驱虫计划通报大规模驱虫药给药对共感染肠道病原体的任何间接影响。ClinicalTrials.gov：NCT02597556。于2015年11月3日注册。本文的在线版本（doi：10.1186/s13063-016-1406-1）包含补充材料，可供授权用户使用。
Anthelmintics are one of the more commonly available classes of drugs to treat infections by parasitic helminths (especially nematodes) in the human intestinal tract. As a result of their cost-effectiveness, mass school-based deworming programs are becoming routine practice in developing countries. However, experimental and clinical evidence suggests that anthelmintic treatments may increase susceptibility to other gastrointestinal infections caused by bacteria, viruses, or protozoa. Hypothesizing that anthelmintics may increase diarrheal infections in treated children, we aim to evaluate the impact of anthelmintics on the incidence of diarrheal disease caused by viral and bacterial pathogens in school children in southern Vietnam. This is a randomized, double-blinded, placebo-controlled trial to investigate the effects of albendazole treatment versus placebo on the incidence of viral- and bacterial-induced diarrhea in 350 helminth-infected and 350 helminth-uninfected Vietnamese school children aged 6–15 years. Four hundred milligrams of albendazole, or placebo treatment will be administered once every 3 months for 12 months. At the end of 12 months, all participants will receive albendazole treatment. The primary endpoint of this study is the incidence of diarrheal disease assessed by 12 months of weekly active and passive case surveillance. Secondary endpoints include the prevalence and intensities of helminth, viral, and bacterial infections, alterations in host immunity and the gut microbiota with helminth and pathogen clearance, changes in mean z scores of body weight indices over time, and the number and severity of adverse events. In order to reduce helminth burdens, anthelmintics are being routinely administered to children in developing countries. However, the effects of anthelmintic treatment on susceptibility to other diseases, including diarrheal pathogens, remain unknown. It is important to monitor for unintended consequences of drug treatments in co-infected populations. In this trial, we will examine how anthelmintic treatment impacts host susceptibility to diarrheal infections, with the aim of informing deworming programs of any indirect effects of mass anthelmintic administrations on co-infecting enteric pathogens. ClinicalTrials.gov: NCT02597556. Registered on 3 November 2015. The online version of this article (doi:10.1186/s13063-016-1406-1) contains supplementary material, which is available to authorized users.