@article {1636, title = {Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition (AMOUR): study protocol for a double-masked randomised controlled trial.}, journal = {BMJ Open}, volume = {15}, year = {2025}, month = {2025 Jul 01}, pages = {e104591}, abstract = {

INTRODUCTION: Amoxicillin is recommended for children with uncomplicated severe acute malnutrition (SAM). However, some trials have shown no difference in amoxicillin for nutritional recovery in children with SAM compared with placebo. In addition, amoxicillin treatment requires two times per day dosing for 7 days, which may influence adherence. Azithromycin is a broad-spectrum antibiotic that can be provided as a single dose and has reduced mortality in children aged 1-59 months when provided by mass drug administration. The AMOUR trial is designed to assess amoxicillin, azithromycin and placebo as part of outpatient treatment of uncomplicated SAM.

METHODS AND ANALYSIS: This double-masked randomised controlled trial will enrol 3000 children over 3 years in an individually randomised 1:1:1 allocation to azithromycin, amoxicillin or placebo arms and follow them for 12 months. Children eligible to enrol in the study will be aged 6-59 months and have uncomplicated non-oedematous SAM as defined by weight-for-height Z-score \<-3 SD and/or mid-upper arm circumference \<115 mm. Additionally, the children must not have received antibiotics in the past 7 days and have not received nutritional programme treatment for SAM in the 2 weeks before enrolling in the study. Each participant will receive a 7-day course of treatment or placebo based on the arm they were randomised to; 1 dose of azithromycin plus placebo for consistency in the number of doses, 7 days of amoxicillin or 7 days of placebo, with the first dose directly observed in all arms. The primary endpoint outcome will be weight gain defined by g/kg/day at 8 weeks. Mortality and relapse will be assessed at 8 weeks and 3 months, 6 months, 9 months and 12 months.

ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Review Board at the University of California, San Francisco (Protocol 23-39411) and the Comit{\'e} d{\textquoteright}Ethique pour la Recherche en Sant{\'e} in Ouagadougou, Burkina Faso (Protocol 2024-01-08). The results of this study will be disseminated to the Ministry of Health, community stakeholders and via peer-reviewed publications and academic conferences.

TRIAL REGISTRATION NUMBER: NCT06010719.

}, keywords = {Amoxicillin, Anti-Bacterial Agents, Azithromycin, Child, Preschool, Double-Blind Method, Female, Humans, Infant, Male, Randomized Controlled Trials as Topic, Severe Acute Malnutrition}, issn = {2044-6055}, doi = {10.1136/bmjopen-2025-104591}, author = {Bountogo, Mamadou and Zakane, Alphonse and Ouedraogo, Thierry A and Ouermi, Lucienne and Compaor{\'e}, Guillaume and Compaor{\'e}, Adama and Coulibaly, Boubacar and Koueta, Fla and Burroughs, Hadley R and Fetterman, Ian and La Mons, Jessica L and Lebas, Elodie and Doan, Thuy and Hsiang, Michelle and O{\textquoteright}Brien, Kieran Sunanda and Arnold, Benjamin and Sie, Ali and Oldenburg, Catherine E} }