CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 924 enrolled / 924 target
Drug / intervention
Dihydroartemisinin-piperaquine (DP) +1 moredrug
Likely dose
Dihydroartemisinin-piperaquine (DP) 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04978272
NCT04978272Phase 3ActiveHigh Momentum (17.5/mo)
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Enhancing Immunity to Malaria in Young Children With Effective Chemoprevention

Grant Dorsey, M.D, Ph.D.·interventional·Posted Jul 27, 2021·Updated Jun 8, 2026

In Brief

A Phase 3 clinical trial evaluating Dihydroartemisinin-piperaquine (DP) and DP Placebo for Malaria. Active but no longer recruiting, targeting 924 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesUganda
CollaboratorsStanford University, Infectious Diseases Research Collaboration, Uganda, National Institute of Allergy and Infectious Diseases (NIAID), Karolinska Institutet

Timeline

Phase 3Active
202220232024202520262027
First PostedJul 27, 2021
Enrollment StartFeb 8, 2022
Primary CompletionMay 5, 2027
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 4.9 years agoPrimary completion in 10 months

Arms & Interventions

IPTc DP 1 yearactive_comparator

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)Other: DP Placebo
IPTc DP 2 yearsactive_comparator

DP given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up.

Drug: Dihydroartemisinin-piperaquine (DP)
No IPTcplacebo_comparator

DP placebo given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up.

Other: DP Placebo

Interventions

Dihydroartemisinin-piperaquine (DP)drug

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.

DP Placeboother

Placebos will be identical appearance to DP.