Comparing Chemoprevention Drugs for School-based Malaria Control

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Completed

CT.gov ID

NCT05980156

Collaborator

Kamuzu University of Health Sciences (Other), Doris Duke Charitable Foundation (Other)

646

Enrollment

Location

Arms

5.4

Actual Duration (Months)

119.2

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Malaria,Falciparum Anemia in Children	Drug: Dihydroartemisinin-Piperaquine Drug: Chloroquine Drug: Sulfadoxine pyrimethamine	Phase 4

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

646 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission: Phase 2 Comparing Drug Regimens

Actual Study Start Date :

Feb 13, 2023

Actual Primary Completion Date :

Jul 28, 2023

Actual Study Completion Date :

Jul 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: 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). Other Names: DP D-Artepp DuoCotecxin Artekin Eurartesim Ridmal Drug: Chloroquine Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2. Other Names: Aralen Hydroxychloroquine Lariago
Experimental: 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).	Drug: Chloroquine Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2. Other Names: Aralen Hydroxychloroquine Lariago 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). Other Names: SP
No Intervention: Control Students will not receive preventive treatment.

Arm

Intervention/Treatment

Experimental: 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).

Drug: 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).

Other Names:

D-Artepp

DuoCotecxin

Artekin

Eurartesim

Ridmal

Drug: Chloroquine

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

Other Names:

Aralen

Hydroxychloroquine

Lariago

Experimental: 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).

Drug: Chloroquine

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

Other Names:

Aralen

Hydroxychloroquine

Lariago

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).

Other Names:

No Intervention: Control

Students will not receive preventive treatment.

Outcome Measures

Primary Outcome Measures

Number of participants with P. falciparum infection [6-8 weeks after the last intervention]
detected by polymerase chain reaction (PCR, binary)

Secondary Outcome Measures

Number of participants with anemia [6-8 weeks after the last intervention]
World Health Organization age-sex definitions (binary)
Mean hemoglobin concentration [6-8 weeks after the last intervention]
g/dL (continuous)
Total parasite density [6-8 weeks after the last intervention]
log transformed (continuous)
Rate of clinical malaria [through study completions, approximately 6 months]
cumulative incidence
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
sustained attention [6-8 weeks after the last intervention]
code transmission test score (continuous)
selective attention [6-8 weeks after the last intervention]
selective attention test score (continuous)
Literacy skills [6-8 weeks after the last intervention]
onetest reading test score (continuous)
Math skills [6-8 weeks after the last intervention]
onetest math score (continuous)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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