Azithromycin in the Outpatient Management of Severe Acute Malnutrition

阿奇霉素在严重急性营养不良门诊治疗中的应用

• 批准号: 10256059
• 负责人: Catherine Elizabeth Oldenburg
• 金额: $ 21.02万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-06 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10256059
• 关键词: Acute; Adherence; Admission activity; Africa; Africa South of the Sahara; Age-Months; Amoxicillin; Antibiotics; Azithromycin; Burkina Faso; Caregivers; Cessation of life; Child; Child Mortality; Clinical; Communicable Diseases; Communities; Conflict (Psychology); Cotrimoxazole; Data; Development; Dose; Feasibility Studies; Guidelines; Half-Life; Immune system; Infection; Kwashiorkor; Lead; Malawi; Malnutrition; Morbidity - disease rate; Niger; Nutritional; Nutritional status; Oral; Outpatients; Pilot Projects; Placebos; Prevalence; Procedures; Randomized; Randomized Controlled Trials; Recovery; Risk; Role; Sampling; Tanzania; Testing; Time; Trachoma; Underweight; Ursidae Family; Visit; Weight Gain; World Health Organization; aged; arm; efficacy testing; evidence based guidelines; follow-up; improved; improved outcome; mortality; mortality risk; peer; primary outcome; programs; randomized placebo controlled trial; rural area; standard of care; trial comparing; wasting

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.

项目总结/摘要 阿莫西林是世界卫生组织（WHO）推荐的治疗该病的有效药物 严重急性营养不良（SAM）因为患有简单SAM的孩子 对于无症状感染，假定使用广谱抗生素治疗可能是有益的， 清除任何现有的感染并改善结果。两项随机安慰剂对照随机试验 已经评估了阿莫西林用于不复杂的SAM，并发现了相互矛盾的结果。这些结果可能 这表明抗生素对简单SAM的治疗没有帮助，或者更好的治疗方法是有效的。 需要抗生素。最近，我们证明，一年两次的大量阿奇霉素分布作为一个单一的口服 在撒哈拉以南非洲，剂量降低了全因儿童死亡率。患有简单SAM的儿童， 相对于营养良好的同龄人，死亡风险升高，可能特别受益于假定的 阿奇霉素治疗。在此，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的比较， 安慰剂我们预计，这些结果将提供有价值的试点数据，并允许改进研究 程序，允许开发一个全面的随机对照试验，以提供证据的作用 阿奇霉素治疗无并发症的SAM。