Azithromycin in the Outpatient Management of Severe Acute Malnutrition

项目摘要/摘要 阿莫西林是世界卫生组织(WHO)推荐的辅助治疗药物 无并发症的严重急性营养不良(SAM)。因为患有简单SAM的儿童更有可能 要有无症状感染，推定使用广谱抗生素治疗可能是有益的，因为 清除任何现有的感染并改善结果。两项随机、安慰剂对照的随机试验 评估了阿莫西林对简单SAM的治疗作用，发现了相互矛盾的结果。这些结果可能 表明抗生素对简单SAM的治疗无济于事，或者更好 需要抗生素。最近，我们证明了两年一次的阿奇霉素单剂量口服分布。 在撒哈拉以南非洲，剂量降低了各种原因造成的儿童死亡率。患有简单SAM的儿童，他们有一个 与营养良好的同龄人相比，死亡率较高的人可能特别受益于 阿奇霉素治疗。在这里，我们建议进行试点和可行性研究，以评估发展潜力。 一项全面的随机对照试验，以测试单剂量阿奇霉素与阿莫西林和 安慰剂。我们预计，结果将提供宝贵的试点数据，并允许改进研究 程序，允许开发一项全面的随机对照试验，为该角色提供证据 阿奇霉素在治疗单纯SAM中的应用。

PROJECT SUMMARY/ABSTRACT Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for the treatment of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM are more likely to have asymptomatic infection, presumptive treatment with a broad-spectrum antibiotic may be beneficial by clearing any existing infection and improving outcomes. Two randomized placebo-controlled randomized trials have evaluated amoxicillin for uncomplicated SAM and have found conflicting results. These results may indicate either that antibiotics are not helpful for the management of uncomplicated SAM, or that a better antibiotic is needed. Recently, we demonstrated that biannual mass azithromycin distribution as a single oral dose reduces all-cause child mortality in sub-Saharan Africa. Children with uncomplicated SAM, who have an elevated risk of mortality relative to their well-nourished peers, may particularly benefit from presumptive azithromycin treatment. Here, we propose a pilot and feasibility study to evaluate the potential for development of a full-scale randomized controlled trial to test a single dose of azithromycin as compared to amoxicillin and placebo. We anticipate that the results will provide valuable pilot data and allow for refinement of study procedures, allowing for development of a full-scale randomized controlled trial to provide evidence for the role of azithromycin in the management of uncomplicated SAM.