Comparing Chemoprevention Drugs for School-based Malaria Control

University of Maryland Baltimore (UMB)

Status and phase: Completed; Phase 4

Conditions: Malaria,Falciparum; Anemia in Children

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05980156

HP-00098250v3

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 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.

Full 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).

Enrollment: 646 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Students (enrolled in the primary intervention)

• Previously enrolled in NCT05244954
• 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 Younger children in participant households (enrolled in the Household Prevalence survey)
• 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

Students (enrolled in the primary intervention)

• 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
• Taking trimethoprim-sulfamethoxazole aka Bactrim or Cotrimoxazole
• Epilepsy
• Psoriasis Household members (enrolled in the Household Prevalence survey)
• Household with more than one school-age child enrolled in the study
• 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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646 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 10 years old and all males) or chloroquine (females 10 years old or older).

Treatment:

Drug: Chloroquine

Drug: Dihydroartemisinin-Piperaquine

Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)

Experimental group

Description:

All students are treated at each intervention. Treatment will be with SP + CQ (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Treatment:

Drug: Sulfadoxine pyrimethamine

Drug: Chloroquine

Control

No Intervention group

Description:

Students will not receive preventive treatment.