ArticleJMIR research protocols2026
Efficacy of Empirical Antibiotics in Community-Based Management of Uncomplicated Severe Acute Malnutrition in Children: Protocol of a Randomized Controlled Trial.
Article in JMIR research protocols, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundAn estimated 17 million children have severe acute malnutrition (SAM) worldwide, with the majority residing in South Asia. Routine empirical antibiotics are prescribed for Community-based Management of Severe Acute Malnutrition (CSAM) to address presumed clinical/subclinical infections and improve nutritional recovery for children with uncomplicated SAM, but low prevalence of infection has been reported. Thus, targeted antibiotics (eg, single-dose azithromycin or 7-day amoxicillin) are recommended over empirical antibiotics to limit emerging antimicrobial resistance (AMR), but there is limited literature on the relevance.
objectiveThis study aims to (1) estimate the prevalence of clinical/subclinical infections and describe AMR patterns among children aged 6-59 months with uncomplicated SAM and assess associations with sociodemographic, clinical, and nutritional factors; (2) explore health-seeking behavior, antibiotic use, and care preferences among caregivers and health care providers; and (3) evaluate the efficacy of 7-day amoxicillin versus single-dose azithromycin versus no antibiotics in weight gain and nutritional recovery among children with SAM.
methodsThis mixed methods study will be part of the ongoing CSAM program implemented in selected districts of Telangana, India. Phase 1 will be a cross-sectional analytical study with a laboratory component to estimate the prevalence of clinical/subclinical infections and AMR among 606 children. Phase 2 will use a qualitative design (focus group discussions with caregivers and in-depth interviews with health care providers) to explore perceptions and practices related to management and antibiotic use among the children. Phase 3 will be an open-label, parallel-group randomized controlled trial (RCT) with three groups of ~250 children each to compare nutritional recovery: 7 days of amoxicillin + standard nutritional care, single-dose azithromycin + standard nutritional care, and no antibiotics + standard nutritional care (control). Children will be followed for up to 6 months, with periodic anthropometric, clinical, and laboratory assessments.
resultsParticipant recruitment began in June 2026. Baseline assessments, interventions, and final evaluations are anticipated to be completed over a 24-month period (ie, by May 2028). Funding was received in August 2025; ethical approval was obtained on February 17, 2025; Clinical Trial Registry - India approval was obtained on March 18, 2025; and administrative approvals from the state government are in process. Preparatory phase activities (ie, obtaining ethical approval, Standard Operating Procedure development, project team recruitment, field site identification, and meeting with district stakeholders and the state government) were completed by March 2026. As there was a delay in initiation of the RCT component of the study, phases 1 and 2 have been initiated after obtaining required approvals at this time.
conclusionsThis study will provide critical evidence on the burden of clinical/subclinical infections and AMR among children aged 6-59 months with uncomplicated SAM and inform the rational use of empirical antibiotics for CSAM amid growing AMR concerns.
trial registrationClinical Trials Registry India CTRI/2025/03/082358; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTIyMDI2&Enc=&userName=.
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