Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi

23-048

This is an individually randomized, controlled, single blind four arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ).Arm 4: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence and disease incidence in young children sleeping student's households to assess the impact on transmission.

2024-10-01

2025-07-01

2025-12-01

Not yet recruiting

Early phase I

1000

Student Inclusion Criteria: * Currently enrolled in the study school * Plan to attend the study school for the remainder of the school year * Parent/guardian available to provide written informed consent Student Exclusion Criteria: * Current evidence of severe malaria or danger signs * Known adverse reaction to the study drugs * History of cardiac problems or fainting * Taking medications known to prolong QT * Family history of prolonged QT * History of epilepsy or psoriasis * Taking cotrimoxazole for long-term prophylaxis Younger child Inclusion Criteria * Slept in the household for most nights in the last month * Age 6-59 months * Parent/guardian available to provide written informed consent Younger child Exclusion Criteria - Current evidence of severe malaria or danger signs

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Students will be randomized to four arms Arm 1: intermittent preventive treatment with dihydroartemisinin-piperaquine (IPTsc-DP); Arm 2: intermittent preventive treatment with sulfadoxine-pyrimethamine plus chloroquine (IPTsc-SPCQ). Arm 3: intermittent preventive treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPTsc-SPAQ); Arm 4 the control arm. Females 13 years and older (likely post-menarche) in Arms 1, 2 and 3 will receive chloroquine alone.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}

2023-10-16