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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Liverpool School of Tropical Medicine
• Collaborator: Kamuzu University of Health Sciences
• Treatments: Amodiaquine; Artenimol; Chloroquine; Fanasil, pyrimethamine drug combination; Hydroxychloroquine; Piperaquine; Pyrimethamine; Sulfadoxine

Criteria

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