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

NCT ID: NCT06083688

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-14
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)

All students are treated at each intervention. Treatment will be with DP (females less than 13 years old and all males) or chloroquine (females 13 years old or older).

Group Type: EXPERIMENTAL

Dihydroartemisinin-Piperaquine

Intervention Type: DRUG

Treatment will be with DP (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older).

Chloroquine

Intervention Type: DRUG

Treatment will be with CQ alone if female and 13 years old or older in both intervention arms.

Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ)

All students are treated at each intervention. Treatment will be with SP and AQ (females less than 13 years old and all males) or chloroquine (females 13 years old or older).

Group Type: EXPERIMENTAL

Chloroquine

Intervention Type: DRUG

Treatment will be with CQ alone if female and 13 years old or older in both intervention arms.

Sulfadoxine-pyrimethamine-amodiaquine

Intervention Type: DRUG

Treatment in Arm 2 (females less than 13 years old and all males).

Control

Students will not receive preventive treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DRUG

Chloroquine

Treatment will be with CQ alone if female and 13 years old or older in both intervention arms.

Intervention Type: DRUG

Sulfadoxine-pyrimethamine-amodiaquine

Treatment in Arm 2 (females less than 13 years old and all males).

Intervention Type: DRUG

Other Intervention Names

DP; D-Artepp; DuoCotecxin; Artekin; Eurartesim; Ridmal; Aralen; Hydroxychloroquine; Lariago; SPAQ; SPAQ-Co

Eligibility Criteria

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

• 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

• 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

• Current evidence of severe malaria or danger signs

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kamuzu University of Health Sciences

OTHER

Sponsor Role: collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Malaria Alert Centre

Blantyre, , Malawi

Countries

Malawi

Other Identifiers

23-048

Identifier Type: -

Identifier Source: org_study_id