Comparing Chemoprevention Approaches for School-based Malaria Control

NCT05244954 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 746

Last updated 2022-11-15

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 screening and treatment (IST) - students will receive treatment if they have a positive high sensitivity rapid diagnostic test (RDT). Arm 2: Intermittent preventive treatment (IPT) - all students will receive treatment. Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, gametocyte carriage and gametocyte density, anemia, cognitive function and educational testing, as well as infection prevalence in student's households to assess the impact on transmission.

Conditions

  • Malaria,Falciparum
  • Anemia in Children

Interventions

DRUG

Dihydroartemisinin-Piperaquine

Treatment of females less than 10 years old and all males in Arm 2 and those who test positive in Arm 1.

DRUG

Chloroquine

Treatment of females 10 years old and older in Arm 2 and those who test positive in Arm 1.

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
2022-02-01
Primary Completion
2022-08-26
Completion
2022-08-26

Countries

  • Malawi

Study Locations

More Related Trials

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 NCT05244954 on ClinicalTrials.gov