At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Single-course Malaria Chemoprevention on Clearance of and Protection From Plasmodium Falciparum Infection in the Presence of Resistance-associated Genotypes in Cameroon
In Brief
A Phase 3 clinical trial evaluating SP (Macleods Pharmaceuticals Ltd), SPAQ (Guilin Pharmaceuticals), and 1 other intervention for Malaria. Completed, enrolled 902 participants across 1 site.
Detailed Summary
The Cameroon 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 900 healthy between 3 to 5 years old who have no symptoms of malaria infection of which 450 children will be assigned to the SP group, 250 to the SPAQ 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 500mg sulfadoxine plus 25mg pyrimethamine as one tablet, and 153mg amodiaquine (as hydrochloride) as one tablet on Day 0, and Children will 153mg amodiaquine (as hydrochloride) as one tablet on days 1 and 2.
Children will receive 4 mg/kg/day for 7 days