Nouna

Researchers are evaluating the use of antibiotics as additional treatment for children aged 6 to 59 months with uncomplicated severe acute malnutrition (SAM) in Burkina Faso. The study compares a single dose of oral azithromycin, a 7-day course of oral amoxicillin, and a placebo to determine their effects on weight gain, nutritional recovery, and the gut microbiome. This Phase 4 trial addresses conflicting past results regarding antibiotic use in uncomplicated SAM and aims to improve treatment guidelines in a region with high malnutrition and child mortality, particularly the Sahel area where food insecurity is seasonal and persistent. Children with SAM will be randomly assigned to one of three groups: a single oral dose of azithromycin at 20 mg/kg followed by placebo doses, a 7-day twice-daily course of oral amoxicillin syrup at an estimated 80 mg/kg divided doses, or a 7-day twice-daily placebo syrup. All participants will also receive ready-to-use therapeutic food according to standard care. The study will take place over three malnutrition seasons in 18 primary healthcare facilities, with weekly follow-ups until nutritional recovery, then assessments at 8 weeks, and every 3 months up to 12 months to monitor relapse and vital status. Participants will be closely monitored through weekly visits during treatment and recovery, with data collected on weight gain as the primary outcome at 8 weeks. Additional follow-ups at 3, 6, 9, and 12 months will track relapse rates and mortality. The study includes tests for appetite using therapeutic food, and excludes children with clinical complications or recent antibiotic use. The trial's findings aim to inform policies on antibiotic use in treating uncomplicated SAM and improve outcomes for vulnerable children in the region.

Researchers are evaluating whether training caregivers to screen children who have recovered from severe acute malnutrition (SAM) using mid-upper arm circumference (MUAC) tapes can reduce the risk of relapse to moderate or severe acute malnutrition. This randomized controlled trial will enroll 1,200 caregiver-child pairs, expanding on a prior pilot study. The study aims to assess the effectiveness of caregiver-administered MUAC screening on relapse rates, speed of relapse detection, and children's anthropometric outcomes, as well as the acceptability of this screening approach from both caregiver and clinic perspectives. Caregivers in two experimental groups will be trained to use MUAC tapes to screen their children weekly for six months after discharge from outpatient nutritional programs. One group will follow the usual monthly clinic visit schedule for three months with a final visit at six months, while the other group will have a reduced follow-up schedule with visits only at three and six months. The third group will receive standard care without caregiver training and will attend monthly clinic visits for three months plus a final visit at six months. Caregivers are instructed to bring their child back to the clinic if the MUAC measurement falls below 11.5 cm, indicating potential relapse. Participants will be assessed at three and six months for relapse and anthropometric outcomes. Caregivers will be surveyed to determine how acceptable they find the MUAC screening process. The primary outcome is the cumulative incidence of relapse over six months. The study will monitor adherence to screening, relapse detection timing, and children's health status through repeated measurements and caregiver reports during the study period.