阿奇霉素用于非复杂性重度急性营养不良：一项试点随机对照试验的研究方案
Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial.
作者信息
O'Brien Kieran S, Sié Ali, Dah Clarisse, Ourohire Millogo, Arzika Ahmed M, Boudo Valentin, Lebas Elodie, Godwin William W, Arnold Benjamin F, Oldenburg Catherine E
机构信息
Francis I Proctor Foundation, University of California, San Francisco, 490 Illinois St, San Francisco, CA, USA.
Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.
出版信息
Pilot Feasibility Stud. 2021 Apr 20;7(1):97. doi: 10.1186/s40814-021-00836-w.
BACKGROUND
Given the high risk of infectious mortality among children with severe acute malnutrition (SAM), the World Health Organization recommends routine administration of a broad-spectrum antibiotic like amoxicillin as part of the management of uncomplicated SAM. However, evidence for the efficacy of amoxicillin to improve nutritional recovery or reduce mortality has been mixed. With a long half-life and evidence of efficacy to reduce mortality in high-risk populations, azithromycin is a potential alternative to amoxicillin in the management of SAM. In this pilot study, we aim to compare the efficacy of azithromycin to amoxicillin to improve nutritional outcomes in children with uncomplicated SAM.
METHODS
This pilot randomized controlled trial will enroll 300 children with uncomplicated SAM from 6 Centre de Santé et de Promotion Sociale in the Boromo health district in Burkina Faso. Eligible children are randomized to receive a single directly observed dose of oral azithromycin or a 7-day course of oral amoxicillin in addition to the standard package of care for uncomplicated SAM. Enrolled children are followed weekly until nutritional recovery, and all children return for a final study visit at 8 weeks after enrollment. Anthropometric indicators, vital status, and clinical outcomes are monitored at each visit and compared by arm. Primary feasibility outcomes include enrollment potential, refusals, loss to follow-up, and completeness of data collection. The primary clinical outcome is weight gain (g/kg/day) over the 8-week study period.
DISCUSSION
This pilot trial will establish the feasibility of conducting a full-scale randomized controlled trial to evaluate alternative antibiotics in this setting and provide preliminary evidence for the efficacy of azithromycin compared to amoxicillin to improve outcomes for children with SAM.
TRIAL REGISTRATION
This trial was first registered on clinicaltrials.gov on 26 June 2018 ( NCT03568643 ).
背景
鉴于重度急性营养不良（SAM）患儿存在较高的感染性死亡风险，世界卫生组织建议常规使用阿莫西林等广谱抗生素作为单纯性SAM管理的一部分。然而，关于阿莫西林改善营养恢复或降低死亡率疗效的证据并不一致。阿奇霉素半衰期长，且有证据表明其对高危人群有降低死亡率的疗效，在SAM管理中是阿莫西林的潜在替代药物。在这项试点研究中，我们旨在比较阿奇霉素与阿莫西林改善单纯性SAM患儿营养结局的疗效。
方法
这项试点随机对照试验将从布基纳法索博罗莫健康区的6个社会健康促进中心招募300名单纯性SAM患儿。符合条件的儿童被随机分配接受单次直接观察剂量的口服阿奇霉素或为期7天的口服阿莫西林疗程，此外还接受单纯性SAM的标准护理套餐。登记入组的儿童每周随访直至营养恢复，所有儿童在入组8周后返回进行最终研究访视。每次访视时监测人体测量指标、生命状态和临床结局，并按组进行比较。主要可行性结局包括入组潜力、拒绝情况、失访情况以及数据收集的完整性。主要临床结局是8周研究期间的体重增加（克/千克/天）。
讨论
这项试点试验将确定在这种情况下进行全面随机对照试验以评估替代抗生素的可行性，并提供与阿莫西林相比阿奇霉素改善SAM患儿结局疗效的初步证据。
试验注册
该试验于2018年6月日首次在clinicaltrials.gov上注册（NCT03568643）。 （注：原文中“2018年6月日”有误，应补充具体日期）
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