Parasite Clearance and Protection from Infection (PCPI) in Cameroon
NCT06173206 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 902
Last updated 2025-03-12
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.
Conditions
Interventions
- DRUG
-
SP (Macleods Pharmaceuticals Ltd)
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
- DRUG
-
SPAQ (Guilin Pharmaceuticals)
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.
- DRUG
-
AS (Guilin Pharmaceuticals)
Children will receive 4 mg/kg/day for 7 days
Sponsors & Collaborators
-
London School of Hygiene and Tropical Medicine
lead OTHER
Principal Investigators
-
R Matthew Chico, MPH, PhD · London School of Hygiene and Tropical Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 5 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-06-10
- Primary Completion
- 2024-12-25
- Completion
- 2025-03-05
Countries
- Cameroon
Study Locations
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