At a glance
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Effect of Single-course Malaria Chemoprevention on Clearance of and Protection From Plasmodium Falciparum Infection in the Presence of Resistance-associated Genotypes in Zambia
In Brief
A Phase 3 clinical trial evaluating SP (Macleods Pharmaceuticals Ltd) and AS (Guilin Pharmaceuticals) for Malaria. Completed, enrolled 600 participants across 1 site.
Detailed Summary
The Zambia PCPI study will measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP. The total number of participants is expected to be 600 healthy between 3 to 5 years old who have no symptoms of malaria infection of which 400 children will be assigned to the SP group and 200 to the AS group. The results of this study will allow to measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP.
Study Details
Timeline
Interventions
Children who weigh \<10kg will receive Sulfadoxine-pyrimethamine paediatric formulation (250mg/12.5mg) dispersable tablets; children who weigh \>10kg will receive 500mg sulfadoxine plus 25mg pyrimethamine
Children will receive 4 mg/kg/day for 7 days