Clinical Trial

An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM

Study acronym: Co-SAM
Active, Not Recruiting Phase 3
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Record status
This record was last updated March 19, 2026 (before its estimated August 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
Malnutrition underlies 45% of child deaths, and has far-reaching educational, economic and health consequences. Severe acute malnutrition (SAM) affects 17 million children globally and is the most life-threatening form of malnutrition. Community-based management of acute malnutrition using ready-to-use therapeutic food (RUTF) has transformed outcomes for children with uncomplicated SAM, but those presenting with poor appetite or medical complications (categorised as having 'complicated' SAM) require hospitalisation. Data show that pneumonia, diarrhoea and malaria are leading causes of death in children with complicated SAM after discharge from hospital. High risk of infectious deaths suggests that sustained antimicrobial interventions may reduce mortality following discharge from hospital. Furthermore, children with complicated SAM respond less well to nutritional rehabilitation, and oftentimes are discharged to a home environment characterised by poverty and multiple caregiver vulnerabilities including depression, low decision making autonomy, lack of social support, gender-restricted family relations, and competing demands on scarce resources. Caregivers have to navigate diverse challenges that impede engagement with clinical care after discharge from hospital. The objective is to address the biological and social determinants of multimorbidity in children with complicated SAM by comparing an antimicrobial intervention with standard of care.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-08-08; most recent amendment 2026-03-17.
Status change: Recruiting → Active, Not Recruiting 2026-02-26
Status change: Not Yet Recruiting → Recruiting 2024-08-13
Trial Details
NCT Number NCT05994742
Lead Sponsor Queen Mary University of London
Collaborators: University of Oxford, KEMRI-Wellcome Trust Collaborative Research Program, University of Washington, Wageningen University, Zvitambo Institute for Maternal & Child Health, Tropical Gastroenterology & Nutrition Group (TROPGAN), University of Cambridge, Kenya Medical Research Institute, National Institute for Health Research, United Kingdom
Conditions Severe Acute Malnutrition, HIV, Comorbidities and Coexisting Conditions, Child Malnutrition
Enrollment 674 participants
Start Date 2024-07-15
Primary Completion 2026-08-15 (estimated)
Study Completion 2026-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-19