An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM
Status:
RECRUITING
Trial end date:
2027-09-15
Target enrollment:
Participant gender:
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 developing multimodal packages of interventions and testing them in a 5-arm adaptive randomized controlled clinical trial, with death/hospitalization or failed nutritional recovery as the primary outcome.
Phase:
PHASE3
Details
Lead Sponsor:
Queen Mary University of London
Collaborators:
KEMRI-Wellcome Trust Collaborative Research Program Kenya Medical Research Institute National Institute for Health Research, United Kingdom Tropical Gastroenterology & Nutrition Group (TROPGAN) University of Cambridge University of Oxford University of Washington Wageningen University Zvitambo Institute for Maternal & Child Health
Treatments:
Azithromycin Child Development Isoniazid Pyridoxine Rifampin Standard of Care