Comparing Chemoprevention Drugs for School-based Malaria Control
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ClinicalTrials.gov Identifier: NCT05980156 |
Recruitment Status :
Completed
First Posted : August 7, 2023
Last Update Posted : August 7, 2023
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Condition or disease | Intervention/treatment | Phase |
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Malaria,Falciparum Anemia in Children | Drug: Dihydroartemisinin-Piperaquine Drug: Chloroquine Drug: Sulfadoxine pyrimethamine | Phase 4 |
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 |
Arm | Intervention/treatment |
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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).
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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:
Drug: Chloroquine Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.
Other Names:
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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).
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Drug: Chloroquine
Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.
Other Names:
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.
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- Number of participants with P. falciparum infection [ Time Frame: 6-8 weeks after the last intervention ]detected by polymerase chain reaction (PCR, binary)
- Number of participants with anemia [ Time Frame: 6-8 weeks after the last intervention ]World Health Organization age-sex definitions (binary)
- Mean hemoglobin concentration [ Time Frame: 6-8 weeks after the last intervention ]g/dL (continuous)
- Total parasite density [ Time Frame: 6-8 weeks after the last intervention ]log transformed (continuous)
- Rate of clinical malaria [ Time Frame: through study completions, approximately 6 months ]cumulative incidence
- 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
- sustained attention [ Time Frame: 6-8 weeks after the last intervention ]code transmission test score (continuous)
- selective attention [ Time Frame: 6-8 weeks after the last intervention ]selective attention test score (continuous)
- Literacy skills [ Time Frame: 6-8 weeks after the last intervention ]onetest reading test score (continuous)
- Math skills [ Time Frame: 6-8 weeks after the last intervention ]onetest math score (continuous)
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Ages Eligible for Study: | 6 Months and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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
Malawi | |
Kamuzu University of Health Sciences | |
Blantyre, Malawi |
Principal Investigator: | Lauren Cohee, MD MS | University of Maryland, Baltimore |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
malaria school chemoprevention preventive treatment |
education cognitive function adolescent hemoglobin |
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 |