A Phase 3 interventional study of Dihydroartemisinin-piperaquine (DP) and DP Placebo in Malaria, sponsored by Grant Dorsey, M.D, Ph.D.. Active, not recruiting at 1 site in Uganda. Open to participants aged Up to 2 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Grant Dorsey, M.D, Ph.D. · Phase 3, Interventional, and Prevention
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.
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.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 924 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Grant Dorsey, M.D, Ph.D. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
DP given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up.
Drug: Dihydroartemisinin-piperaquine (DP)
DP placebo given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up.
Other: DP Placebo
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.
Also known as: Duo-Cotecxin
Placebos will be identical appearance to DP.
Incidence of symptomatic malaria following cessation of IPTc
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.
Time frame: 2 years to 4 years of age
Incidence of complicated malaria
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).
Time frame: 2 years to 4 years of age
Incidence of hospital admissions and/or deaths
Admission to the pediatric ward for any cause, and deaths of any cause
Time frame: 2 years to 4 years of age
Prevalence of parasitemia
Proportion of routine visits with asexual parasites detected by blood smears or quantitative polymerase chain reaction (qPCR).
Time frame: 2 years to 4 years of age
Prevalence of anemia
Proportion of routine hemoglobin measurements \<11 grams/dL
Time frame: 2 years to 4 years of age
Plan to share: No
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Grant Dorsey, M.D, Ph.D.