Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 4, 2026
Date Accepted: May 18, 2026
Efficacy of empirical antibiotics in Community-Based Management of Uncomplicated Severe Acute Malnutrition in Children: A Randomized Controlled Trial Protocol
ABSTRACT
Background:
Globally, an estimated 17 million children have Severe Acute Malnutrition (SAM), with the majority residing in the South Asia region. The World Health Organization (WHO) recommends routine empirical antibiotics for community-based management of SAM (CSAM) to address presumed clinical or subclinical infections and improve nutritional recovery for the uncomplicated SAM children. However, a few studies reported low prevalence of infection among uncomplicated SAM and varied antibiograms. Thus, suggested targeted over empirical antibiotics to limit emerging antimicrobial resistance (AMR). Recent evidence from the African region reports that a single dose of azithromycin has been found effective in CSAM, and a few trials even contemplate the use of antibiotics in CSAM. The national guidelines (2013) from India recommend empirical amoxicillin for seven days, there is limited literature on the relevance of this recommendation from India context.
Objective:
The objectives are i) to estimate the prevalence of clinical and subclinical infections and describe AMR patterns among children aged 6–59 months with uncomplicated SAM, and to assess associations with socio-demographic, clinical, and nutritional factors; ii) to explore health-seeking behaviour, antibiotic use, and care preferences among caregivers and healthcare providers; and iii) to evaluate the efficacy of one week of Amoxicillin vs single dose of Azithromycin vs no antibiotics on weight gain and nutritional recovery among SAM children.
Methods:
This mixed-methods study will be embedded in the ongoing CSAM program implemented in the selected districts of Telangana, India. Objective i will be a cross-sectional analytical study with a laboratory component to estimate the prevalence of clinical, subclinical infections and AMR among approximately 606 uncomplicated SAM children (6-59 months). Objective ii employs a qualitative design, including focus group discussions with caregivers and in-depth interviews with healthcare providers, to explore perceptions and practices related to uncomplicated SAM management and antibiotic use. Objective iii is an open-label, randomized, parallel-group controlled trial enrolling approximately 250 children in each group to compare nutritional recovery among three groups: standard care plus amoxicillin, standard care plus single-dose azithromycin, and standard care without antibiotics. Children will be followed for up to 6 months with periodic anthropometric, clinical, and laboratory assessments.
Results:
Participant recruitment is expected to begin in April 2026. Baseline assessments, interventions, and final evaluations are anticipated to be completed over a 24-month period.
Conclusions:
This study will generate critical evidence on the burden of clinical, subclinical infections and AMR among Uncomplicated SAM children aged 6-59 months and inform the rational use of empirical antibiotics for CSAM amid growing antimicrobial resistance concerns. Clinical Trial: Clinical Trials Registry- India (CTRI) CTRI/2025/03/082358; https://ctri.nic.in/Clinicaltrials/advsearch.php
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