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Modifying Immunity in Children With DihydROartemisinin-Piperaquine (MIC-DroP)
Sponsor: Grant Dorsey, M.D, Ph.D.
Summary
The MIC-DroP trial will test the hypothesis that preventing early life blood-stage malaria antigenic exposure with intermittent preventive therapy (IPT) enhances protective immunity to malaria. This study will take advantage of a unique opportunity to study infants born to mothers followed in a NIH-funded randomized controlled trial of novel intermittent preventive therapy in pregnancy (IPTp) regimens (NCT04336189). MIC-DroP will leverage the parent IPTp study to enroll 924 children who will be randomized at 8 weeks of age to receive no intermittent preventive therapy in childhood (IPTc), monthly DP from 8 weeks to 1 year of age, or monthly DP from 8 weeks to 2 years of age, and then follow children to 4 years of age. The primary outcome of this study will be to compare the incidence of malaria from 2 to 4 years of age among children randomized to receive no IPTc, monthly DP for the first year of life, or monthly DP for the first two years of life. Investigators will also leverage this trial to evaluate immune development during early childhood.
Official title: Enhancing Immunity to Malaria in Young Children With Effective Chemoprevention
Key Details
Gender
All
Age Range
Any - 2 Months
Study Type
INTERVENTIONAL
Enrollment
924
Start Date
2022-02-08
Completion Date
2026-08-31
Last Updated
2025-04-02
Healthy Volunteers
Yes
Conditions
Interventions
Dihydroartemisinin-piperaquine (DP)
Duo-Cotecxin 20mg/160mg tabs by Holley-Cotec, Beijing, China Each treatment with DP will consist of half-strength tablets given once a day for 3 consecutive days according to weight-based guidelines.
DP Placebo
Placebos will be identical appearance to DP.
Locations (1)
IDRC - Tororo Research Clinic
Tororo, Uganda