Modifying Immunity in Children With DihydROartemisinin-Piperaquine (MIC-DroP)
Status:
Not yet recruiting
Trial end date:
2026-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Grant Dorsey, M.D, Ph.D.
Collaborators:
Infectious Diseases Research Collaboration, Uganda Karolinska Institutet National Institute of Allergy and Infectious Diseases (NIAID) Stanford University