Co-SAM: An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated Severe Acute Malnutrition

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug, Behavioral, Other, Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: f
View:

• Age 6-59 months, of either sex

• Hospitalised with complicated severe acute malnutrition, as per WHO definition

• Started transition to RUTF

• Caregiver willing and able to attend the study clinic for all visits

• Caregiver able and willing to give informed consent

Locations
Other Locations
Zambia
Matero Hospital
RECRUITING
Lusaka
UTH - University Teaching Hospital
RECRUITING
Lusaka
Zimbabwe
Chitungwiza Central Hospital
RECRUITING
Harare
Parirenyatwa Hospital
RECRUITING
Harare
Sally Mugabe Hospital
RECRUITING
Harare
Contact Information
Primary
Isabella Cordani, BSc
i.cordani@qmul.ac.uk
+ 44 (0)2078822800
Backup
Andrew Prendergast, DPhil MRCPCH
a.prendergast@qmul.ac.uk
+44 (0) 207 882 2269
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2027-09-15
Participants
Target number of participants: 1266
Treatments
Active_comparator: Arm 1: Standard-of-care (control)
Children in the control arm will receive Ready to Use Therapeutic Food (RUTF) for at least 2 weeks, plus all standard care. Children with HIV will receive long-term Cotrimoxazole prophylaxis and antiretroviral therapy, as per current guidelines.
Experimental: Arm 2: Antimicrobial package
Children will receive a bundle of azithromycin (3 days every month), isoniazid (daily), rifampicin (daily) and pyridoxine (daily) for 12 weeks.
Experimental: Arm 3: Reformulated RUTF
Children will receive a reformulated RUTF, with increased medium-chain triglycerides (MCTs), higher hydrolysed protein content and a more bioavailable form of selenium (selenium yeast). Children will receive RUTF for at least 2 weeks.
Experimental: Arm 4: Psychosocial package
Caregiver-child pairs will receive a low-cost, co-designed intervention to strengthen caregiver support, enhance income generation and promote child play. This is delivered over 12 weeks and comprises:~i) The Friendship Bench, developed 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.~ii) Care for Child Development is a UNICEF package that helps families build stronger relationships and solve problems in caring for the child at home, through play and communication activities in a series of age-appropriate interactive modules delivered by a lay worker using 'flash' cards.~iii) 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.
Experimental: Arm 5: Antimicrobial package + reformulated RUTF + psychosocial package
A combination of all interventions from arms 2, 3 and 4, plus standard care delivered for 12 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Tropical Gastroenterology & Nutrition Group (TROPGAN), University of Oxford, University of Cambridge, University of Washington, Kenya Medical Research Institute, Zvitambo Institute for Maternal & Child Health, KEMRI-Wellcome Trust Collaborative Research Program, Wageningen University, National Institute for Health Research, United Kingdom
Leads: Queen Mary University of London

This content was sourced from clinicaltrials.gov