MCAZ CTR:: Applications

PUBLIC TITLE/ACRONYM	COMBI
Scientific Title	Cotrimoxazole for Mothers to improve birth weight in infants
Primary Sponsor Details
Sponsors *	Zvitambo
Secondary Sponsor Details
Contact for Public Queries
Name	Sr Dzivaidzo Chidhanguro
Designation	District Hub Manager
Email	d.chidhanguro@zvitambo.com
Phone number	+263-712620782
Postal Address	No 16 Lauchlan Avenue, Meyrick Park, Mabelreign Harare
Affiliation	Zvitambo
Contact for Scientific Queries
Name	Professor S Munjanja
Designation	Principal Investigator
Email	spmunjanja@gmail.com
Phone number	+263-772516846
Postal Address	82 The Chase, Mount Pleasant, Harare, Zimbabwe
Affiliation	University of Zimbabwe
Countries of Recruitment
Zimbabwe

Source of Funds	MRC UK, WELCOME TRUST

Health Condition(s) or Problem(s) Studied	This is a proof-of-concept trial designed to evaluate whether cotrimoxazole prophylaxis during pregnancy improves birth weight by reducing SGA and preterm birth.

Medicine Name	Cotrimoxazole
Quantity of medicine required	Daily dose of 960mg of cotrimoxazole in two tablets, each 480g

7.0 PRINCIPAL INCLUSION CRITERIA
Women must meet all of the following inclusion criteria: Confirmed pregnant Known HIV status in the current pregnancy Willing to receive all their antenatal care at one of the study clinics
7.1 PRINCIPAL EXCLUSION CRITERIA
None of the following exclusion criteria must be met: Currently receiving or eligible to receive cotrimoxazole prophylaxis^a Contraindication to cotrimoxazole^b Any other acute or chronic condition that might interfere with the study, as judged by the research clinician^c
7.2 PRIMARY END POINTS
Infant birth weight.

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

Expected Number of participants in Zimbabwe	1000
Total enrolment in each site: (if competitive enrolment, state minimum and maximum number per site.)	1000
Total participants worldwide	1000

Time period for the trial	24 Months

Medicines Control Authority of Zimbabwe