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

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.

Timeline

Start

2024-07-15

Primary completion

2026-08-15

Completion

2026-08-15

Publications

• Bwakura-Dangarembizi M, Amadi B, Singa BO, Muyemayema S, Ngosa D, Mwalekwa L, Ngao N, Kazhila L, Mutasa B, Mpofu E, Mudawarima L, Gonzales GB, Mudzingwa S, Mutenda M, Keter LK, Mutasa K, Njunge JM, Jones H, Phiri TN, Mudibo E, Chulu N, Majo FD, Chasekwa B, Tembo A, Nyabinda C, Oduol C, Sauramba V, Tavengwa NV, Langhaug L, Cordani I, Smuk M, Jaki T, Ntozini R, Walson J, Tickell KD, Berkley J, Kelly P, Prendergast AJ; Co-SAM Trial Team. An adaptive multiarm randomised trial of biomedical and psychosocial interventions to improve convalescence following severe acute malnutrition in sub-Saharan Africa: Co-SAM trial protocol. BMJ Open. 2025 May 24;15(5):e093758. doi: 10.1136/bmjopen-2024-093758.

Drugs

Indications