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Modifying Immunity in Children With DihydROartemisinin-Piperaquine (MIC-DroP)
Recruiting
I'm InterestedTrial ID: NCT04978272
Purpose
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
Stanford Investigator(s)
Prasanna Jagannathan
Assistant Professor of Medicine (Infectious Diseases) and of Microbiology and Immunology
Eligibility
Inclusion Criteria:
1. Born to HIV-uninfected mother enrolled in parent clinical trial of intermittent
preventative treatment of malaria in pregnancy (IPTp-SP vs. IPTp-DP vs. IPTp-SP+DP,
NCT 04336189)
2. Resident of Busia District
3. Provision of informed consent by parent/guardian
4. Agreement to present for any illness and avoid, where possible, medications outside
the study protocol.
Exclusion Criteria:
1. Intention of moving outside Busia district during the study period
2. Active medical problem requiring in-patient evaluation or chronic medical condition
requiring frequent medical attention
Intervention(s):
other: DP Placebo
drug: Dihydroartemisinin-piperaquine (DP)
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Prasanna Jagannathan
650-724-5343