Comparing Chemoprevention Drugs for School-based Malaria Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

646 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2023-07-28

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Malaria,Falciparum Anemia in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Students were randomized to three arms in the original trial. In this follow-on study, students will remain in their study arms. Arm 1 which previously received intermittent screening-and-treatment will now receive intermittent preventive treatment with sulfadoxine-pyrimethamine plus chloroquine. Arm 2 which received intermittent preventive treatment with dihydroartemisinin-piperaquine will again receive intermittent preventive treatment with dihydroartemisinin-piperaquine. Arm 3 the control arm will continue as a control. Females 10 years and older (potentially post-menarche) in Arms 1 and 2 will receive chloroquine alone.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Laboratory technicians processing samples will be blinded to participant's study arm.

Study Groups

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

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).

Group Type EXPERIMENTAL

Dihydroartemisinin-Piperaquine

Intervention Type DRUG

Treatment will be with DP (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

Chloroquine

Intervention Type DRUG

Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.

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

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).

Group Type EXPERIMENTAL

Chloroquine

Intervention Type DRUG

Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.

Sulfadoxine pyrimethamine

Intervention Type DRUG

Treatment will be with SP and chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

Control

Students will not receive preventive treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dihydroartemisinin-Piperaquine

Treatment will be with DP (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

Intervention Type DRUG

Chloroquine

Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.

Intervention Type DRUG

Sulfadoxine pyrimethamine

Treatment will be with SP and chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

Intervention Type DRUG

Other Intervention Names

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DP D-Artepp DuoCotecxin Artekin Eurartesim Ridmal Aralen Hydroxychloroquine Lariago SP

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes