MCAZ CTR:: Applications

PUBLIC TITLE/ACRONYM
Scientific Title	An adaptive multi-arm trial to improve clinical outcomes among children recovering from complicated severe acute malnutrition (Co-SAM)
Primary Sponsor Details
Sponsors *	Queen Mary University of London
Secondary Sponsor Details
Contact for Public Queries
Name	Mrs Virginia Sauramba
Designation	Research Administration and Compliance Manager
Email	v.sauramba@zvitambo.com
Phone number	+263 783 910 622
Postal Address	No. 16 Lauchlan Ave., Meyrick Park, Mabelreign
Affiliation
Contact for Scientific Queries
Name	Dr Mutsa Bwakura-Dangarembizi
Designation	PI
Email	dangas@zol.co.zw
Phone number	+263772601735
Postal Address	No. 16 Lauchlan Ave., Meyrick Park, Mabelreign
Affiliation
Countries of Recruitment
Kenya Zambia Zimbabwe

Source of Funds	Queen Mary University of London

Health Condition(s) or Problem(s) Studied	Severe acute malnutrition

Medicine Name	Rifampicin, Isoniazid, Azithromycin
Quantity of medicine required	N/A

7.0 PRINCIPAL INCLUSION CRITERIA
Age 6-59 months, of either sex Hospitalised with complicated severe acute malnutrition, as per WHO definition Started transition from therapeutic milk feeds to RUTF Caregiver willing and able to attend the study clinic for all visits Caregiver able and willing to give informed consent
7.1 PRINCIPAL 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
7.2 PRIMARY END POINTS
The primary endpoints for this trial will be death or first hospitalisation or failed nutritional recovery within 24 weeks post-randomisation.

9.0 DESIGN OF THE TRIAL
Type of trial	Opened
If controlled
Randomised
Single Blind
Double Blind
Parallel group
Cross over
Other
If yes to other, specify
If controlled, specify the comparator
Other medicinal product(s)	No
Placebo	No
Other	No
If yes to other, specify
Other

Expected Number of participants in Zimbabwe	422
Total enrolment in each site: (if competitive enrolment, state minimum and maximum number per site.)	422
Total participants worldwide	1266

Time period for the trial	1 Jan 2024 to 31 Dec 2026

Medicines Control Authority of Zimbabwe