Co-SAM: An adaptive multi-arm trial to improve clinical outcomes among children recovering from complicated severe acute malnutrition
We believe there is an urgent need to improve recovery in children with complicated severe acute malnutrition (SAM) after they leave hospital, by tackling underlying medical and social causes of ill-health. In this project, we bring together two networks of researchers from southern and east Africa with extensive experience in SAM.
The team secured a grant of £4.9 million from National Institute for Health and Care Research (NIHR) to undertake this project.
A Phase III trial will start in 2023, enrolling 1266 children with complicated SAM in Zambia, Zimbabwe and Kenya. There are five interventional arms which children may be randomly allocated to, for a 12 week intervention period:
Study participants will then be followed up at 24 weeks. The primary outcome is a composite of death or hospitalisation or failed nutritional recovery by 24 weeks post-randomisation.