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

Phase 4

Recruiting

• Conditions: Malaria,Falciparum; Anemia in Children
• Interventions: Drug: Dihydroartemisinin-Piperaquine; Drug: Chloroquine; Drug: Sulfadoxine-pyrimethamine-amodiaquine

• Registration Number: NCT06083688
• Lead Sponsor: Liverpool School of Tropical Medicine

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.

Study Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-16
• Status Verified: 2024-10
• Study Start: 2024-10-14
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)	Dihydroartemisinin-Piperaquine	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).
Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)	Chloroquine	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).
Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ)	Chloroquine	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).
Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ)	Sulfadoxine-pyrimethamine-amodiaquine	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).

Primary Outcome Measures

Name	Time	Method
Number of participants with P. falciparum infection	6-8 weeks after the last intervention	detected by polymerase chain reaction (PCR, binary)
Number of participants with anemia	6-8 weeks after the last intervention	World Health Organization age-sex definitions (binary)
Rate of clinical malaria	through study completion (approximately 6 months), and 6 months following the intervention	cumulative incidence

Secondary Outcome Measures

Name	Time	Method
Mean hemoglobin concentration	6-8 weeks after the last intervention	g/dL (continuous)
Literacy skills	6-8 weeks after the last intervention	Early grade reading assessment
Math skills	6-8 weeks after the last intervention	Early grade math assessment
Rate of school absenteeism among participants	through study completion (approximately 6 months)	Proportion of days absent among days where attendance is assessed
P. falciparum prevalence among children less than 5 years old living in households with study participants	6-8 weeks after the last intervention	detected by PCR
Rate of clinical malaria among children less than 5 years old living in households with study participants	through study completion (approximately 6 months)	cumulative incidence

Trial Locations

Locations (1)

Malaria Alert Centre; 🇲🇼 Blantyre, Malawi