NCT05980156

Comparing Chemoprevention Drugs for School-based Malaria Control

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 646 (actual)
• Sponsor: University of Maryland, Baltimore · 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 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.

Detailed description

Students attending a single primary school in Machinga District, Malawi who were enrolled in NCT05244954 were offered enrollment in this follow-on study. The intervention will be conducted every 6-weeks during the two 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 10 years old and all males) or chloroquine (females 10 years old or older. Students in the IPT-SPCQ arm will be treated with sulfadoxine-pyrimethamine plus chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

Conditions

• Malaria,Falciparum
• Anemia in Children

Interventions

Type	Name	Description
DRUG	Dihydroartemisinin-Piperaquine	Treatment will be with DP (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).
DRUG	Chloroquine	Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.
DRUG	Sulfadoxine pyrimethamine	Treatment will be with SP and chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

Timeline

• Start date: 2023-02-13
• Primary completion: 2023-07-28
• Completion: 2023-07-28
• First posted: 2023-08-07
• Last updated: 2023-08-07

Locations

1 site across 1 country: Malawi