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Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition (AMOUR): study protocol for a
Mamadou Bountogo1,2, Alphonse Zakane1, Thierry A Ouedraogo1
1Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso.
Insights
This study compares azithromycin, amoxicillin, and placebo for treating severe acute malnutrition (SAM) in children. The AMOUR trial investigates which antibiotic, if any, improves nutritional recovery and survival in young children with SAM.
Area of Science:
- Pediatric infectious diseases
- Nutritional science
- Clinical trial methodology
Background:
- Amoxicillin is standard for severe acute malnutrition (SAM), but effectiveness and adherence are concerns.
- Azithromycin, a single-dose antibiotic, has shown mortality benefits in children.
- The AMOUR trial evaluates azithromycin, amoxicillin, and placebo for uncomplicated SAM outpatient treatment.
Purpose of the Study:
- To compare the efficacy of azithromycin, amoxicillin, and placebo in treating uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months.
- To assess the impact of these treatments on nutritional recovery, mortality, and relapse rates.
- To evaluate adherence factors associated with different antibiotic dosing regimens.
Main Methods:
- A double-masked, randomized controlled trial involving 3000 children aged 6-59 months with uncomplicated SAM.
- Participants are randomized 1:1:1 to receive azithromycin (single dose), amoxicillin (7-day course), or placebo for 7 days.
- Primary outcome is weight gain at 8 weeks; secondary outcomes include mortality and relapse assessed up to 12 months.
Main Results:
- Primary endpoint: weight gain (g/kg/day) at 8 weeks.
- Secondary endpoints: mortality and relapse assessed at 8 weeks, 3, 6, 9, and 12 months.
- Trial registration: NCT06010719.
Conclusions:
- The AMOUR trial will provide crucial data on optimal antibiotic strategies for severe acute malnutrition.
- Findings will inform treatment guidelines for pediatric malnutrition, potentially improving recovery rates and reducing mortality.
- Results will be disseminated to health authorities, stakeholders, and the scientific community.
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 Comité d'Ethique pour la Recherche en Santé 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.
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