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

Liverpool School of Tropical Medicine

Status and phase: Active, not recruiting; Phase 4

Conditions: Malaria,Falciparum; Anemia in Children

Treatments: Drug: Sulfadoxine-pyrimethamine-amodiaquine; Drug: Dihydroartemisinin-Piperaquine; Drug: Chloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT06083688

23-048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Student 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 3 patient groups

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

Experimental group

Description:

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).

Treatment:

Drug: Chloroquine

Drug: Dihydroartemisinin-Piperaquine

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

Experimental group

Description:

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).

Treatment:

Drug: Chloroquine

Drug: Sulfadoxine-pyrimethamine-amodiaquine

Control

No Intervention group

Description:

Students will not receive preventive treatment.