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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 6Months - 59MonthsAll GendersPhase 4
1 location
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Actively Recruiting

Healthy Volunteer

This research investigates training caregivers to screen children who have recovered from severe acute malnutrition SAM using mid-upper arm circumference MUAC tapes. The study aims to find out if this training can reduce relapse risk to moderate or severe acute malnutrition and improve early detection times. It also evaluates how acceptable this screening method is to both caregivers and clinics. The trial involves children aged 6 to 54 months who recently recovered from uncomplicated SAM treated in outpatient programs. Participants are randomized into three groups one receives usual care with no caregiver MUAC training and monthly clinic visits for 3 months plus a follow-up at 6 months the second group receives caregiver MUAC screening training with weekly home screening plus the usual monthly clinic visits and a 6-month follow-up the third group also receives caregiver MUAC screening training but with a reduced clinic visit schedule, attending only at 3 and 6 months post enrollment. Caregivers are counseled to bring their child to the clinic if their childs MUAC falls below 11.5 cm, indicating relapse. During the 6 months following enrollment, caregivers will screen their children weekly at home if trained, and all children will be assessed clinically at 3 and 6 months for outcomes. Researchers will measure relapse incidence, time to relapse detection, and anthropometric outcomes. Surveys will assess caregiver acceptance of MUAC training. The study plans to enroll 1200 caregiver-child pairs to better understand if caregiver screening improves relapse detection and child health after SAM recovery.

Age: 6Months - 54MonthsAll GendersPhase Not Applicable
1 location