Effect of Single-course Malaria Chemoprevention on Clearance of and Protection From Plasmodium Falciparum Infection in the Presence of Resistance-associated Genotypes in Zambia

2022-KEP-813

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.

2024-02-15

2024-10-15

2025-02-15

Not yet recruiting

Early phase I

600

Inclusion Criteria: * Be 3-5 years old * Exhibit no symptoms of malaria * Have parents/guardians willing to have their child participate in all follow-up visits and seek care from study staff * Reside in the study catchment area Exclusion Criteria: * Have evidence of acute illness as determined by clinical examination * Exhibit symptoms of malaria (axillary fever ≥ 37.5 °C and / or history of fever in past 48 hours) * Have known allergy to study medications * Have received antimalarial treatment or azithromycin within 28 days prior to screening * Be concomitantly receiving co-trimoxazole (trimethoprim-sulfamethoxazole) * Be categorised as severely malnourished according to WHO child growth standards

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Children assigned to group 1-SP will receive a 7-day course of placebo artesunate, whereas children in the group 2-AS will be given a 7-day course of active artesunate. This will span Day -7, -6, -5, -4, -3, -2, and -1. Then, on Day 0, children who had been given placebo artesunate will receive SP, whereas children in the AS group will receive placebo SP.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Fully placebo controlled', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}

2023-12-21