A Phase 4 interventional study of Dihydroartemisinin-Piperaquine and Chloroquine in Malaria,Falciparum and Anemia in Children, sponsored by University of Maryland, Baltimore. Completed at 1 site in Malawi. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Prevention
This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent screening and treatment (IST) - students will receive treatment if they have a positive high sensitivity rapid diagnostic test (RDT). Arm 2: Intermittent preventive treatment (IPT) - all students will receive treatment. Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, gametocyte carriage and gametocyte density, anemia, cognitive function and educational testing, as well as infection prevalence in student's households to assess the impact on transmission.
Students will be enrolled in a single primary school in Machinga District, Malawi. The intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission. Students in the IPT are and those that test positive in the IST arm will be treatment with dihydroartemisinin-piperaquine (DP) (females less than 10 years old and all males) or chloroquine (females 10 years old or older).
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This study's enrollment of 746 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
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Students (enrolled in the primary intervention)
Exclusion Criteria:
Students (enrolled in the primary intervention)
Students will be screened for infection using a higher sensitivity malaria rapid diagnostic test and treated if positive. 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 · Drug: Chloroquine
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 · Drug: Chloroquine
Students will not receive preventive treatment.
Treatment of females less than 10 years old and all males in Arm 2 and those who test positive in Arm 1.
Also known as: DP, DuoCotecxin, Artekin, Eurartesim, Ridmal
Treatment of females 10 years old and older in Arm 2 and those who test positive in Arm 1.
Also known as: Aralen
P. falciparum infection
detected by polymerase chain reaction (PCR, binary)
Time frame: 6-8 weeks after the last intervention
P. falciparum gametocyte carriage
detected by q-rtPCR (binary)
Time frame: 6-8 weeks after the last intervention
Number of participant with anemia
World Health Organization age-sex definitions (binary)
Time frame: 6-8 weeks after the last intervention
Mean hemoglobin concentration
g/dL (continuous)
Time frame: 6-8 weeks after the last intervention
Total parasite density
log transformed (continuous)
Time frame: 6-8 weeks after the last intervention
Gametocyte density
log transformed (continuous)
Time frame: 6-8 weeks after the last intervention
Rate of clinical malaria
cumulative incidence
Time frame: from the first intervention to 6-8 weeks after the last intervention
P. falciparum prevalence among household members
detected by PCR
Time frame: 6-8 weeks after the last intervention
Cognitive function test scores
standardized scores
Time frame: 6-8 weeks after the last intervention
Reading test scores
standardized scores
Time frame: 6-8 weeks after the last intervention
Math test scores
standardized scores
Time frame: 6-8 weeks after the last intervention
School attendance
number of days missed based on registers and spot checks
Time frame: from the first intervention to 6-8 weeks after the last intervention
Mean infectiousness
regression modeled infectiousness based on gametocyte density, gametocyte sex ratio, symptom status, and other predictors of infectiousness
Time frame: from the first intervention to 6-8 weeks after the last intervention
Performance characteristics of conventional RDT
compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score
Time frame: through study completion, on average 6 months
Performance characteristics of high-sensitivity RDT
compared to PCR to detect: P. falciparum infection, P. falciparum parasite density, anemia, hemoglobin, gametocytemia, gametocyte density, and potential infectiousness score
Time frame: through study completion, on average 6 months
Plan to share: Yes — all individual participant data that underlie results in a publication
Supporting information: Study protocol, Icf
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore