Malaria Clinical Trial
Official title:
The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children
To evaluate if intermittent preventive treatment in infants (IPTi) consisting of SP [Fansidar] given through the EPI scheme alongside routine immunisations at 3, 4 and 9 months of age reduces de incidence of clinical malaria up to 12 months of age
The study is a randomised, double blind, placebo-controlled trial of the antimalarial drug
sulphadoxine-pyrimethamine administered intermittently at 3, 4 and 9 months of age through
the EPI scheme at the time of routine immunisations.
Children will be randomized into placebo and SP treatment groups by block randomization, and
it is expected a similar age distribution and a similar number of children in each group.
Doses of sulphadoxine (25 mg/kg)-pyrimethamine (1.25 mg/kg) (SP) or placebo will be given by
a health assistant according to bodyweight (a quarter of a tablet for those <5kg, a half for
those 5-10 kg, and a whole tablet for children >10 kg). The tablets will be crashed and
diluted with water for their administration.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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