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An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM
Sponsor: Queen Mary University of London
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.
Official title: Co-SAM: An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated Severe Acute Malnutrition
Key Details
Gender
All
Age Range
6 Months - 59 Months
Study Type
INTERVENTIONAL
Enrollment
674
Start Date
2024-07-15
Completion Date
2026-08-15
Last Updated
2026-03-19
Healthy Volunteers
No
Interventions
Rifampicin
Rifampicin is commonly used in the first-line management of paediatric tuberculosis, and is approved by the FDA (ID: 2862628) and the EMA (EMA/31710/2020).
Azithromycin
Azithromycin is a macrolide antibiotic, and is approved for use in children by the FDA (ID: 3263750) and EMA (EMA/2872/2021).
Isoniazid
Isoniazid is an antibiotic commonly used in the firstline treatment of tuberculosis, and as tuberculosis prophylaxis.
Pyridoxine Hydrochloride
Pyridoxine is a form of vitamin B6 used to prevent peripheral neuropathy among children receiving isoniazid.
Standard Care
All children will receive care according to WHO guidelines, which includes standard RUTF and any other medications required.
The Friendship Bench
The Friendship Bench was developed in Zimbabwe as a low-cost psychological intervention utilising problem-solving therapy (delivered by trained lay workers) and peer-to-peer support to address depression and other common mental disorders. There is a strong evidence-base for its use in urban LMIC settings. Peer support groups meet every 1-2 weeks and focus on communal problem solving, and establishing income-generation activities (such as making bags).
Care for Child Development
Care for Child Development is a UNICEF package that helps families build stronger relationships and solve problems in caring for their child at home, through play and communication activities to stimulate children, through a series of age-appropriate interactive modules delivered by a lay worker using 'flash' cards. It has been used in other African contexts and has good acceptability.
Other Behavioural Support
Educational and behaviour-change messages around better nutrition; play for children with SAM; stigma, HIV and gender-based violence; financial planning; causes of SAM; and health-seeking behaviours. These have been developed with caregivers affected by SAM in a previous study, through a series of co-design workshops, ensuring they are contextually relevant.
Locations (9)
Homa Bay
Homa Bay, Kenya
Mbagathi Hospital
Mbagathi, Kenya
Migori Referral Hospital
Migori, Kenya
Coast General
Mombasa, Kenya
Matero Hospital
Lusaka, Zambia
UTH - University Teaching Hospital
Lusaka, Zambia
Chitungwiza Central Hospital
Harare, Zimbabwe
Parirenyatwa Hospital
Harare, Zimbabwe
Sally Mugabe Hospital
Harare, Zimbabwe