Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission: Phase 2 Comparing Drug Regimens

HP-00098250v3

This is an individually randomized, controlled, single blind three 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: 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 in young children sleeping student's households to assess the impact on transmission.

2023-02-13

2023-07-28

2023-07-28

Completed

Early phase I

646

Inclusion Criteria: Students (enrolled in the primary intervention) * Previously enrolled in NCT05244954 * 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 Younger children in participant households (enrolled in the Household Prevalence survey) * Slept in the household for most nights in the last month * Age 6-59 months * Parent/guardian available to provide written informed consent Exclusion Criteria: Students (enrolled in the primary intervention) * 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 * Taking trimethoprim-sulfamethoxazole aka Bactrim or Cotrimoxazole * Epilepsy * Psoriasis Household members (enrolled in the Household Prevalence survey) * Household with more than one school-age child enrolled in the study * Current evidence of severe malaria or danger signs

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Students were randomized to three arms in the original trial. In this follow-on study, students will remain in their study arms. Arm 1 which previously received intermittent screening-and-treatment will now receive intermittent preventive treatment with sulfadoxine-pyrimethamine plus chloroquine. Arm 2 which received intermittent preventive treatment with dihydroartemisinin-piperaquine will again receive intermittent preventive treatment with dihydroartemisinin-piperaquine. Arm 3 the control arm will continue as a control. Females 10 years and older (potentially post-menarche) in Arms 1 and 2 will receive chloroquine alone.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': "Laboratory technicians processing samples will be blinded to participant's study arm.", 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 646, 'type': 'ACTUAL'}}

2023-08-07