The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Chemoprevention Drugs for School-based Malaria Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05980156
Recruitment Status : Completed
First Posted : August 7, 2023
Last Update Posted : August 7, 2023
Sponsor:
Collaborators:
Kamuzu University of Health Sciences
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Lauren Cohee, University of Maryland, Baltimore

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
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 : February 13, 2023
Actual Primary Completion Date : July 28, 2023
Actual Study Completion Date : July 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: SP
No Intervention: Control
Students will not receive preventive treatment.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Secondary Outcome Measures :
  1. Number of participants with anemia [ Time Frame: 6-8 weeks after the last intervention ]
    World Health Organization age-sex definitions (binary)

  2. Mean hemoglobin concentration [ Time Frame: 6-8 weeks after the last intervention ]
    g/dL (continuous)

  3. Total parasite density [ Time Frame: 6-8 weeks after the last intervention ]
    log transformed (continuous)

  4. Rate of clinical malaria [ Time Frame: through study completions, approximately 6 months ]
    cumulative incidence

  5. 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. sustained attention [ Time Frame: 6-8 weeks after the last intervention ]
    code transmission test score (continuous)

  7. selective attention [ Time Frame: 6-8 weeks after the last intervention ]
    selective attention test score (continuous)

  8. Literacy skills [ Time Frame: 6-8 weeks after the last intervention ]
    onetest reading test score (continuous)

  9. Math skills [ Time Frame: 6-8 weeks after the last intervention ]
    onetest math score (continuous)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05980156


Locations
Layout table for location information
Malawi
Kamuzu University of Health Sciences
Blantyre, Malawi
Sponsors and Collaborators
University of Maryland, Baltimore
Kamuzu University of Health Sciences
Doris Duke Charitable Foundation
Investigators
Layout table for investigator information
Principal Investigator: Lauren Cohee, MD MS University of Maryland, Baltimore
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Lauren Cohee, Assistant Professor of Pediatrics, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT05980156    
Other Study ID Numbers: HP-00098250v3
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: August 7, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all individual participant data that underlie results in a publication
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: After results publication
Access Criteria: Public access with registration to allow tracking

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lauren Cohee, University of Maryland, Baltimore:
malaria
school
chemoprevention
preventive treatment
 education
cognitive function
adolescent
hemoglobin
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Infections
Mosquito-Borne Diseases
Vector Borne Diseases
Hydroxychloroquine
Chloroquine
Pyrimethamine
Piperaquine
Sulfadoxine
 Fanasil, pyrimethamine drug combination
Artenimol
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides
Folic Acid Antagonists
Anti-Infective Agents, Urinary