Status:
RECRUITING
An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
University of Oxford
KEMRI-Wellcome Trust Collaborative Research Program
Conditions:
Severe Acute Malnutrition
HIV
Eligibility:
All Genders
6-59 years
Phase:
PHASE3
Brief 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 lif...
Detailed Description
This is a 5-arm randomized, unblinded clinical trial comparing: Arm 1: Standard-of-care (control) Arm 2: Antimicrobial package Arm 3: Reformulated RUTF Arm 4: Psychosocial package Arm 5: Antimicrobia...
Eligibility Criteria
Inclusion
- 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
- Any acute or chronic condition which mean that receipt of one or more study interventions, or participation in the trial, would not be advisable.
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
1266 Patients enrolled
Trial Details
Trial ID
NCT05994742
Start Date
July 15 2024
End Date
September 1 2027
Last Update
November 18 2025
Active Locations (5)
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1
Matero Hospital
Lusaka, Zambia
2
UTH - University Teaching Hospital
Lusaka, Zambia
3
Chitungwiza Central Hospital
Harare, Zimbabwe
4
Parirenyatwa Hospital
Harare, Zimbabwe