Trial Comparing Azithromycin, Amoxicillin, and Placebo for Treating Uncomplicated Severe Acute Malnutrition in Children Aged 6 to 59 Months

What this Trial Is About

Researchers are evaluating the use of antibiotics as part of treatment for children aged 6 to 59 months with uncomplicated severe acute malnutrition SAM. This trial compares azithromycin, amoxicillin, and placebo to determine their effects on weight gain, nutritional recovery, and gut health. The study addresses uncertainty about whether antibiotics help manage uncomplicated SAM and aims to provide evidence that may influence treatment guidelines, focusing on a vulnerable region in Burkina Faso where malnutrition is highly seasonal and a significant health concern. Children will be randomly assigned to one of three groups a single oral dose of azithromycin followed by placebo for 7 days, a 7-day twice-daily course of amoxicillin, or a 7-day twice-daily course of placebo. All children will receive ready-to-use therapeutic food according to standard care. The trial will take place over three malnutrition seasons at multiple health facilities, with a total follow-up period of 12 months. Participants will be assessed weekly until nutritional recovery and then at 8 weeks, 3, 6, 9, and 12 months to monitor weight gain, relapse, mortality, and other health outcomes. Researchers will collect data on weight gain as the primary outcome at 8 weeks, along with secondary outcomes like time to recovery, need for inpatient care, and mortality over 12 months. The study includes close monitoring and support, ensuring children receive full outpatient care throughout the trial.

Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition