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

NCT06083688 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 23-048
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria,Falciparum; Anemia in Children

Keywords

IPTsc; school; chemoprevention; intermittent preventive treatment; malaria transmission

Outcome Measures

Primary Outcomes (3)

• Number of participants with P. falciparum infection

  detected by polymerase chain reaction (PCR, binary)

  6-8 weeks after the last intervention

• Number of participants with anemia

  World Health Organization age-sex definitions (binary)

  6-8 weeks after the last intervention

• Rate of clinical malaria

  cumulative incidence

  through study completion (approximately 6 months), and 6 months following the intervention

Secondary Outcomes (6)

• Mean hemoglobin concentration

  6-8 weeks after the last intervention

• Literacy skills

  6-8 weeks after the last intervention

• Math skills

  6-8 weeks after the last intervention

• Rate of school absenteeism among participants

  through study completion (approximately 6 months)

• P. falciparum prevalence among children less than 5 years old living in households with study participants

  6-8 weeks after the last intervention

Other Outcomes (1)

• Total parasite density

  6-8 weeks after the last intervention

Study Arms (3)

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

EXPERIMENTAL

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).

Drug: Dihydroartemisinin-Piperaquine; Drug: Chloroquine

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

EXPERIMENTAL

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).

Drug: Chloroquine; Drug: Sulfadoxine-pyrimethamine-amodiaquine

Control

NO INTERVENTION

Students will not receive preventive treatment.

Interventions

Dihydroartemisinin-Piperaquine DRUG

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

Also known as: DP, D-Artepp, DuoCotecxin, Artekin, Eurartesim, Ridmal

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

Chloroquine DRUG

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

Also known as: Aralen, Hydroxychloroquine, Lariago

Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP); Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ)

Sulfadoxine-pyrimethamine-amodiaquine DRUG

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

Also known as: SPAQ, SPAQ-Co

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

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Slept in the household for most nights in the last month
• Age 6-59 months
• Parent/guardian available to provide written informed consent
• \- Current evidence of severe malaria or danger signs

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• Kamuzu University of Health Sciences: collaborator

Study Sites (1)

Malaria Alert Centre

Blantyre, Malawi

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Chloroquine; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Students will be randomized to three arms Arm 1: intermittent preventive treatment with dihydroartemisinin-piperaquine (IPTsc-DP); Arm 2: intermittent preventive treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPTsc-SPAQ); Arm 3 the control arm. Females 13 years and older (likely post-menarche) in Arms 1 and 2 will receive chloroquine alone.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: October 14, 2024
• Primary Completion: July 31, 2025
• Study Completion: January 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication
• Access Criteria: Public access with registration to allow tracking

Locations

MA (1)