Improving outcomes for children recovering from severe acute malnutrition
Co-SAM: An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated Severe Acute Malnutrition
This study is testing different ways to help young children recover from severe malnutrition while in the hospital to see which method works best for keeping them healthy and preventing further hospital visits.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1266 (estimated) |
| Ages | 6 Months to 59 Months |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 5 sites (Lusaka and 4 other locations) |
| Trial ID | NCT05994742 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance recovery in children aged 6-59 months who are hospitalized with complicated severe acute malnutrition (SAM). It compares five different intervention approaches, including standard care, antimicrobial treatments, reformulated therapeutic food, and psychosocial support, to determine which is most effective in preventing death or hospitalization and ensuring nutritional recovery. The trial is adaptive, allowing for modifications based on interim analyses of the intervention arms. Children will be followed for 24 weeks post-discharge to assess their health outcomes.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-59 months who are hospitalized with complicated severe acute malnutrition and are transitioning to ready-to-use therapeutic food.
Not a fit: Patients with acute or chronic conditions that contraindicate participation in the trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could significantly reduce mortality and improve recovery rates in children suffering from complicated severe acute malnutrition.
How similar studies have performed: Other studies have shown promising results with similar interventions in managing severe acute malnutrition, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Any acute or chronic condition which mean that receipt of one or more study interventions, or participation in the trial, would not be advisable.
Where this trial is running
Lusaka and 4 other locations
- Matero Hospital — Lusaka, Zambia (Recruiting)
- UTH - University Teaching Hospital — Lusaka, Zambia (Recruiting)
- Chitungwiza Central Hospital — Harare, Zimbabwe (Recruiting)
- Parirenyatwa Hospital — Harare, Zimbabwe (Recruiting)
- Sally Mugabe Hospital — Harare, Zimbabwe (Recruiting)
Study contacts
- Study coordinator: Isabella Cordani, BSc
- Email: i.cordani@qmul.ac.uk
- Phone: + 44 (0)2078822800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.