Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Grant Dorsey, M.D, Ph.D.

Collaborator: Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Dihydroartemisinin-piperaquine (DP)
  • Other: DP Placebo

Phase:

Phase 3

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

Ages Eligible for Study

N/A - 2 Months

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting