Comparing Chemoprevention Drugs for School-based Malaria Control

August 4, 2023 updated by: Lauren Cohee, University of Maryland, Baltimore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

646

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Blantyre, Malawi
        • Kamuzu University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Students will not receive preventive 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:
  • Eurartesim
  • Artekin
  • Ridmal
  • DP
  • DuoCotecxin
  • D-Artepp
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with P. falciparum infection
Time Frame: 6-8 weeks after the last intervention
detected by polymerase chain reaction (PCR, binary)
6-8 weeks after the last intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean hemoglobin concentration
Time Frame: 6-8 weeks after the last intervention
g/dL (continuous)
6-8 weeks after the last intervention
Total parasite density
Time Frame: 6-8 weeks after the last intervention
log transformed (continuous)
6-8 weeks after the last intervention
Number of participants with anemia
Time Frame: 6-8 weeks after the last intervention
World Health Organization age-sex definitions (binary)
6-8 weeks after the last intervention
Rate of clinical malaria
Time Frame: through study completions, approximately 6 months
cumulative incidence
through study completions, approximately 6 months
P. falciparum prevalence among children less than 5 years old living in households with study participants
Time Frame: 6-8 weeks after the last intervention
detected by PCR
6-8 weeks after the last intervention
sustained attention
Time Frame: 6-8 weeks after the last intervention
code transmission test score (continuous)
6-8 weeks after the last intervention
selective attention
Time Frame: 6-8 weeks after the last intervention
selective attention test score (continuous)
6-8 weeks after the last intervention
Literacy skills
Time Frame: 6-8 weeks after the last intervention
onetest reading test score (continuous)
6-8 weeks after the last intervention
Math skills
Time Frame: 6-8 weeks after the last intervention
onetest math score (continuous)
6-8 weeks after the last intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

Kamuzu University of Health Sciences
Doris Duke Charitable Foundation

Investigators

  • Principal Investigator: Lauren Cohee, MD MS, University of Maryland School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2023

Primary Completion (Actual)

July 28, 2023

Study Completion (Actual)

July 28, 2023

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00098250v3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all individual participant data that underlie results in a publication

IPD Sharing Time Frame

After results publication

IPD Sharing Access Criteria

Public access with registration to allow tracking

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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