Modifying Immunity in Children With DihydROartemisinin-Piperaquine (MIC-DroP)

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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
• Treatments: Artenimol; Dihydroartemisinin; Piperaquine

Criteria

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