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

June 4, 2026 updated by: Grant Dorsey, M.D, Ph.D.

Enhancing Immunity to Malaria in Young Children With Effective Chemoprevention

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a phase III, double-blind, randomized controlled trial of 924 HIV- uninfected children. Children born to mothers enrolled in an ongoing clinical trial of different IPTp arms in pregnancy (NCT 04336189) will be enrolled in this study. In the parent IPTp study, 2757 HIV-uninfected pregnant women will be randomized to receive IPTp with monthly sulfadoxine pyrimethamine (SP) alone, monthly DP alone, or both monthly SP+DP, and followed through 4 weeks postpartum. At the 4-week postpartum visit, we will enroll and randomize 924 eligible children to one of three IPTc arms: no IPTc (the current standard of care), monthly DP from 8 weeks to 1 year of age, or monthly DP from 8 weeks to 2 years of age. Study drugs will be placebo controlled and all doses of study drug will be given by directly observed therapy (DOT). The intervention phase will be completed at 2 years of age, and children followed through 4 years of age. Study participants will be followed for all of their outpatient medical care in our dedicated study clinic. Malaria incidence will be measured via active case detection. Routine assessments will be performed in the study clinic for all study participants every 4 weeks, including passive surveillance for parasitemia by quantitive polymerase chain reaction (qPCR). Venous blood will be collected for immunologic assays three times annually from 8 weeks to 4 years of age. All maternal assessments conducted during the parent IPTp study, including assessment for maternal malaria exposure (e.g., placental histology) household survey, will be available and linked to each study participant.

Study Type

Interventional

Enrollment (Actual)

924

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Tororo, Uganda
        • IDRC - Tororo Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IPTc DP 1 year
DP given from 8 weeks to 52 weeks of age; DP placebo given from 52 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up.
Drug: 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.
Other Names:
  • Duo-Cotecxin
Other: DP Placebo
Placebos will be identical appearance to DP.
Active Comparator: IPTc DP 2 years
DP given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up.
Drug: 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.
Other Names:
  • Duo-Cotecxin
Placebo Comparator: No IPTc
DP placebo given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up.
Other: DP Placebo
Placebos will be identical appearance to DP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of symptomatic malaria following cessation of IPTc
Time Frame: 2 years to 4 years of age
The incidence of symptomatic malaria, defined as the number of incident episodes of malaria requiring treatment per time at risk, during the period after the intervention was given (2-4 years of age). Treatments within 14 days of a prior episode are not considered incident events.
2 years to 4 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complicated malaria
Time Frame: 2 years to 4 years of age
Any incident episode of malaria meeting World Health Organization criteria for severe malaria or danger signs per time at risk, during the period after the intervention was given (2-4 years of age).
2 years to 4 years of age
Incidence of hospital admissions and/or deaths
Time Frame: 2 years to 4 years of age
Admission to the pediatric ward for any cause, and deaths of any cause
2 years to 4 years of age
Prevalence of parasitemia
Time Frame: 2 years to 4 years of age
Proportion of routine visits with asexual parasites detected by blood smears or quantitative polymerase chain reaction (qPCR).
2 years to 4 years of age
Prevalence of anemia
Time Frame: 2 years to 4 years of age
Proportion of routine hemoglobin measurements <11 grams/dL
2 years to 4 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grant Dorsey, M.D, Ph.D.

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Karolinska Institutet
Stanford University
Infectious Diseases Research Collaboration, Uganda

Investigators

  • Principal Investigator: Prasanna Jagannathan, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2022

Primary Completion (Estimated)

May 5, 2027

Study Completion (Estimated)

May 5, 2027

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

July 23, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIC-DroP
  • U01AI155325 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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