Back to resultsComparing Chemoprevention Drugs for School-based Malaria Control
Primary Purpose
Malaria,Falciparum, Anemia in Children
Status
Completed
Phase
Phase 4
Locations
Malawi
Study Type
Interventional
Intervention
Dihydroartemisinin-Piperaquine
Chloroquine
Sulfadoxine pyrimethamine
Sponsored by
About this trial
This is an interventional prevention trial for Malaria,Falciparum focused on measuring malaria, school, chemoprevention, preventive treatment, education, cognitive function, adolescent, hemoglobin
Eligibility 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
Sites / Locations
- Kamuzu University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)
Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)
Control
Arm Description
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).
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).
Students will not receive preventive treatment.
Outcomes
Primary Outcome Measures
Number of participants with P. falciparum infection
detected by polymerase chain reaction (PCR, binary)
Secondary Outcome Measures
Number of participants with anemia
World Health Organization age-sex definitions (binary)
Mean hemoglobin concentration
g/dL (continuous)
Total parasite density
log transformed (continuous)
Rate of clinical malaria
cumulative incidence
P. falciparum prevalence among children less than 5 years old living in households with study participants
detected by PCR
sustained attention
code transmission test score (continuous)
selective attention
selective attention test score (continuous)
Literacy skills
onetest reading test score (continuous)
Math skills
onetest math score (continuous)
Full Information
NCT ID
NCT05980156
First Posted
July 28, 2023
Last Updated
August 4, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
Kamuzu University of Health Sciences, Doris Duke Charitable Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05980156
Brief Title
Comparing Chemoprevention Drugs for School-based Malaria Control
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
July 28, 2023 (Actual)
Study Completion Date
July 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Kamuzu University of Health Sciences, Doris Duke Charitable Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria,Falciparum, Anemia in Children
Keywords
malaria, school, chemoprevention, preventive treatment, education, cognitive function, adolescent, hemoglobin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Laboratory technicians processing samples will be blinded to participant's study arm.
Allocation
Randomized
Enrollment
646 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)
Arm Type
Experimental
Arm Description
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).
Arm Title
Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Students will not receive preventive treatment.
Intervention Type
Drug
Intervention Name(s)
Dihydroartemisinin-Piperaquine
Other Intervention Name(s)
DP, D-Artepp, DuoCotecxin, Artekin, Eurartesim, Ridmal
Intervention Description
Treatment will be with DP (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Other Intervention Name(s)
Aralen, Hydroxychloroquine, Lariago
Intervention Description
Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.
Intervention Type
Drug
Intervention Name(s)
Sulfadoxine pyrimethamine
Other Intervention Name(s)
SP
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of participants with P. falciparum infection
Description
detected by polymerase chain reaction (PCR, binary)
Time Frame
6-8 weeks after the last intervention
Secondary Outcome Measure Information:
Title
Number of participants with anemia
Description
World Health Organization age-sex definitions (binary)
Time Frame
6-8 weeks after the last intervention
Title
Mean hemoglobin concentration
Description
g/dL (continuous)
Time Frame
6-8 weeks after the last intervention
Title
Total parasite density
Description
log transformed (continuous)
Time Frame
6-8 weeks after the last intervention
Title
Rate of clinical malaria
Description
cumulative incidence
Time Frame
through study completions, approximately 6 months
Title
P. falciparum prevalence among children less than 5 years old living in households with study participants
Description
detected by PCR
Time Frame
6-8 weeks after the last intervention
Title
sustained attention
Description
code transmission test score (continuous)
Time Frame
6-8 weeks after the last intervention
Title
selective attention
Description
selective attention test score (continuous)
Time Frame
6-8 weeks after the last intervention
Title
Literacy skills
Description
onetest reading test score (continuous)
Time Frame
6-8 weeks after the last intervention
Title
Math skills
Description
onetest math score (continuous)
Time Frame
6-8 weeks after the last intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Cohee, MD MS
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kamuzu University of Health Sciences
City
Blantyre
Country
Malawi
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
33767384
Citation
Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/s41598-021-86450-5.
Results Reference
background
PubMed Identifier
33222799
Citation
Cohee LM, Opondo C, Clarke SE, Halliday KE, Cano J, Shipper AG, Barger-Kamate B, Djimde A, Diarra S, Dokras A, Kamya MR, Lutumba P, Ly AB, Nankabirwa JI, Njagi JK, Maiga H, Maiteki-Sebuguzi C, Matangila J, Okello G, Rohner F, Roschnik N, Rouhani S, Sissoko MS, Staedke SG, Thera MA, Turner EL, Van Geertruyden JP, Zimmerman MB, Jukes MCH, Brooker SJ, Allen E, Laufer MK, Chico RM. Preventive malaria treatment among school-aged children in sub-Saharan Africa: a systematic review and meta-analyses. Lancet Glob Health. 2020 Dec;8(12):e1499-e1511. doi: 10.1016/S2214-109X(20)30325-9. Epub 2020 Oct 22.
Results Reference
background
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Comparing Chemoprevention Drugs for School-based Malaria Control
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