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Comparing Chemoprevention Drugs for School-based Malaria Control

NCT05980156 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 646

Last updated 2023-08-07

No results posted yet for this study

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.

Conditions

  • Malaria,Falciparum
  • Anemia in Children

Interventions

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).

DRUG

Chloroquine

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

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).

Sponsors & Collaborators

  • Kamuzu University of Health Sciences

    collaborator OTHER

  • Doris Duke Charitable Foundation

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Lauren Cohee, MD MS · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2023-07-28
Completion
2023-07-28

Countries

  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05980156 on ClinicalTrials.gov