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
Sponsor study identifier
interventional
646
1 country
1
Study Start
February 13, 2023
Actual (reported)Primary Completion
July 28, 2023
Actual (reported)Study Completion
July 28, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 28, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 13, 2023
Actual (reported)July 28, 2023
Actual (reported)July 28, 2023
Actual (reported)July 28, 2023
Actual (reported)August 7, 2023
Actual (reported)Number of participants with P. falciparum infection
detected by polymerase chain reaction (PCR, binary)
6-8 weeks after the last intervention
Number of participants with anemia
6-8 weeks after the last intervention
Mean hemoglobin concentration
6-8 weeks after the last intervention
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).
Treatment will be with DP (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).
Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.
Kamuzu University of Health Sciences
Blantyre, Malawi
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.
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.
Lauren Cohee, MD MS
University of Maryland, Baltimore
646 participants (actual enrollment reported by the registry).
First Submitted
July 28, 2023
Total parasite density
6-8 weeks after the last intervention
Rate of clinical malaria
through study completions, approximately 6 months
P. falciparum prevalence among children less than 5 years old living in households with study participants
6-8 weeks after the last intervention
Students will not receive preventive treatment.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Posted
August 7, 2023
Study Start
February 13, 2023
Actual (reported)Primary Completion
July 28, 2023
Actual (reported)Study Completion
July 28, 2023
Actual (reported)Last Updated
August 7, 2023
Record last verified: 2023-08
all individual participant data that underlie results in a publication
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Source: ClinicalTrials.gov.
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