NCT06083688

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Liverpool School of Tropical Medicine · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

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 amodiaquine (AQ) (IPT-SPAQ). 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 and disease incidence in young children sleeping student's households to assess the impact on transmission.

Detailed description

Students attending primary school in rural Blantyre District, Malawi will be offered enrollment in this study. The intervention will be conducted every 6-weeks during the school terms which coincide with peak malaria transmission. Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine (DP) (females less than 13 years old and all males) or chloroquine (females 13 years old or older). Students in the IPT-SPAQ arm will be treated with sulfadoxine-pyrimethamine plus amodiaquine (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). Students in the all arms will receive routine malaria education.

Conditions

• Malaria,Falciparum
• Anemia in Children

Interventions

Type	Name	Description
DRUG	Dihydroartemisinin-Piperaquine	Treatment will be with DP (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older).
DRUG	Chloroquine	Treatment will be with CQ alone if female and 13 years old or older in both intervention arms.
DRUG	Sulfadoxine-pyrimethamine-amodiaquine	Treatment in Arm 2 (females less than 13 years old and all males).

Timeline

• Start date: 2024-10-14
• Primary completion: 2025-07-31
• Completion: 2026-01-01
• First posted: 2023-10-16
• Last updated: 2025-11-19

Locations

1 site across 1 country: Malawi