Efficacy of Empirical Antibiotics in Community-Based Management of Uncomplicated Severe Acute Malnutrition in Children: Protocol of a Randomized Controlled Trial.
Gomathi Ramaswamy, Sirisha Cheela, Kishore Yadav Jothula et al.
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In 30 seconds
This randomized controlled trial aims to evaluate the efficacy of 7-day amoxicillin versus single-dose azithromycin versus no antibiotics in promoting weight gain and nutritional recovery in children aged 6-59 months with uncomplicated severe acute malnutrition (SAM) in Telangana, India. The study will also assess the prevalence of infections and antimicrobial resistance patterns. Recruitment began in June 2026, with completion expected by May 2028.
Key findings
- The study will involve approximately 250 children in each of the three intervention groups.
- Phase 1 will estimate the prevalence of clinical/subclinical infections among 606 children.
- The trial will follow participants for up to 6 months to assess nutritional recovery.
Why it matters
Understanding the effectiveness of targeted antibiotic treatments in children with uncomplicated SAM is crucial for optimizing management strategies and addressing concerns about antimicrobial resistance, which is increasingly relevant in pediatric care.