Francis I Proctor Foundation, University of California, San Francisco, California.
Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.
Am J Trop Med Hyg. 2022 Jan 10;106(3):930-938. doi: 10.4269/ajtmh.21-1023.
Azithromycin is a promising alternative to amoxicillin in the management of uncomplicated severe acute malnutrition (SAM) as it can be administered as a single dose and has efficacy against several pathogens causing infectious disease and mortality in children under 5. In this pilot trial, we aimed to establish the feasibility of a larger randomized controlled trial and provide preliminary evidence comparing the effect of azithromycin to amoxicillin on weight gain in children with uncomplicated SAM. We enrolled children 6-59 months old with uncomplicated SAM at six healthcare centers in Burkina Faso. Participants were randomized to a single dose of azithromycin or a 7-day course of amoxicillin and followed weekly until nutritional recovery and again at 8 weeks. Apart from antibiotics, participants received standard of care, which includes ready-to-use therapeutic food. Primary feasibility outcomes included enrollment potential, refusals, and loss to follow-up. The primary clinical outcome was weight gain (g/kg/day) over 8 weeks. Outcome assessors were masked. Between June and October 2020, 312 children were screened, 301 were enrolled with zero refusals, and 282 (93.6%) completed the 8-week visit. Average weight gain was 2.5 g/kg/day (standard deviation [SD] 2.0) in the azithromycin group and 2.6 (SD 1.7) in the amoxicillin group (mean difference -0.1, 95% CI -0.5 to 0.3, P = 0.63). Fewer adverse events were reported in the azithromycin group (risk ratio 0.50, 95% CI 0.31-0.82, P = 0.006). With strong enrollment and follow-up, a fully powered trial in this setting is feasible.
阿奇霉素作为阿莫西林的替代方案，有望用于治疗单纯性严重急性营养不良（SAM），因为它可以单剂量给药，且对引起 5 岁以下儿童感染性疾病和死亡的几种病原体具有疗效。在这项试点试验中，我们旨在确定更大规模随机对照试验的可行性，并提供比较阿奇霉素和阿莫西林对单纯性 SAM 儿童体重增加效果的初步证据。我们在布基纳法索的 6 个医疗中心招募了年龄在 6-59 个月、患有单纯性 SAM 的儿童。参与者被随机分配接受单剂量阿奇霉素或 7 天疗程的阿莫西林治疗，并在每周随访一次，直至营养恢复，然后在 8 周时再次随访。除了抗生素外，参与者还接受了标准护理，包括即食治疗食品。主要可行性结局包括入组潜力、拒绝和失访。主要临床结局是 8 周时的体重增加（g/kg/天）。结局评估者是盲法的。在 2020 年 6 月至 10 月期间，共筛选了 312 名儿童，301 名被纳入研究，没有拒绝入组者，282 名（93.6%）完成了 8 周随访。阿奇霉素组的平均体重增加为 2.5 g/kg/天（标准差[SD] 2.0），阿莫西林组为 2.6（SD 1.7）（平均差异-0.1，95%置信区间-0.5 至 0.3，P=0.63）。阿奇霉素组报告的不良事件较少（风险比 0.50，95%置信区间 0.31-0.82，P=0.006）。在这种情况下，具有较强的入组和随访能力，完全有能力开展一项充分的试验。
