MalariaPhase 3MIC-DroPNCT04978272
Modifying Immunity in Children With DihydROartemisinin-Piperaquine (MIC-DroP)
A Phase 3 study testing Dihydroartemisinin-piperaquine (DP) in people with Malaria, run by Grant Dorsey, M.D, Ph.D. at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Dihydroartemisinin-piperaquine (DP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 924 participants
- Where
- 1 siteUganda
- Study dates
- 8 Feb 2022to 5 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
- Resident of Busia District
- Provision of informed consent by parent/guardian
- Agreement to present for any illness and avoid, where possible, medications outside the study protocol.
Who cannot join
- Intention of moving outside Busia district during the study period
- Active medical problem requiring in-patient evaluation or chronic medical condition requiring frequent medical attention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Malaria
- Being tested
- Dihydroartemisinin-piperaquine (DP), DP Placebo
- Keywords
- dihydroartemisinin-piperaquine, intermittent preventive therapy, children, immune response
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-piperaquine (DP)Drug
Also called Duo-Cotecxin
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.
| Study group | Role | What they receive |
|---|---|---|
| IPTc DP 1 year | Active 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. Receives: Drug: Dihydroartemisinin-piperaquine (DP); Other: DP Placebo |
| IPTc DP 2 years | Active comparator | DP given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up. Receives: Drug: Dihydroartemisinin-piperaquine (DP) |
| No IPTc | Placebo comparator | DP placebo given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up. Receives: Other: DP Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years to 4 years of age
Secondary outcomes (4)
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).
Measured: 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
Measured: 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).
Measured: 2 years to 4 years of age
Prevalence of anemia
Proportion of routine hemoglobin measurements <11 grams/dL
Measured: 2 years to 4 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start8 Feb 2022
- Primary completion5 May 2027 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Double blinded randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 924 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grant Dorsey, M.D, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Infectious Diseases Research Collaboration, Uganda, National Institute of Allergy and Infectious Diseases (NIAID), Karolinska Institutet
- Responsible party
- Sponsor-investigator, Grant Dorsey, M.D, Ph.D., University of California, San Francisco
- Investigators
- Prasanna Jagannathan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978272
- Sponsor's protocol ID
- MIC-DroP
- Other IDs
- U01AI155325
- Acronym
- MIC-DroP
- Status last verified
- Jun 2026
- First submitted
- 23 Jul 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dobbs KR, Jagannathan P, Dechavanne C. Editorial: Immune tolerance and human malaria. Front Immunol. 2024 Jul 4;15:1450480. doi: 10.3389/fimmu.2024.1450480. eCollection 2024. No abstract available.
PubMed 39026667Nideffer J, Jagannathan P. Type I regulatory T cells in malaria: of mice and men. J Clin Invest. 2023 Jan 3;133(1):e166019. doi: 10.1172/JCI166019.
PubMed 36594472Hughes E, Wallender E, Kajubi R, Jagannathan P, Ochieng T, Kakuru A, Kamya MR, Clark TD, Rosenthal PJ, Dorsey G, Aweeka F, Savic RM. Piperaquine-Induced QTc Prolongation Decreases With Repeated Monthly Dihydroartemisinin-Piperaquine Dosing in Pregnant Ugandan Women. Clin Infect Dis. 2022 Aug 31;75(3):406-415. doi: 10.1093/cid/ciab965.
PubMed 34864925Li J, Wang X, Lackner AI, Narasimhan P, Li L, Mallajosyula V, Johnson MM, Hobler AL, Kirosingh AS, Braun AE, Nankya F, Musinguzi K, Kakuru A, Kamya M, Rosenthal PJ, Dorsey G, Jagannathan P, Angelo M, Pollheimer J, Gaw SL, Winn VD, Nadeau KC, Davis MM. Regulatory KIR+CD8+ T cells are elevated during human pregnancy. Sci Transl Med. 2025 Aug 6;17(810):eadm7697. doi: 10.1126/scitranslmed.adm7697. Epub 2025 Aug 6.
PubMed 40768597Roh ME, Gutman J, Murphy M, Hill J, Madanitsa M, Kakuru A, Barsosio HC, Kariuki S, Lusingu JPA, Mosha F, Kajubi R, Kamya MR, Mathanga D, Chinkhumba J, Laufer MK, Mlugu E, Kamuhabwa AAR, Aklillu E, Minzi O, Okoro RN, Geidam AD, Ohieku JD, Desai M, Jagannathan P, Dorsey G, Ter Kuile FO. Dihydroartemisinin-piperaquine versus sulfadoxine-pyrimethamine for intermittent preventive treatment of malaria in pregnancy: a systematic review and individual participant data meta-analysis. medRxiv [Preprint]. 2024 Nov 26:2024.11.23.24315401. doi: 10.1101/2024.11.23.24315401.
PubMed 39649586Tukwasibwe S, Lewis SN, Taremwa Y, van der Ploeg K, Press KD, Ty M, Namirimu Nankya F, Musinguzi K, Nansubuga E, Bach F, Chamai M, Okitwi M, Tumusiime G, Nakimuli A, Colucci F, Kamya MR, Nankabirwa JI, Arinaitwe E, Greenhouse B, Dorsey G, Rosenthal PJ, Ssewanyana I, Jagannathan P. Natural killer cell antibody-dependent cellular cytotoxicity to Plasmodium falciparum is impacted by cellular phenotypes, erythrocyte polymorphisms, parasite diversity and intensity of transmission. Clin Transl Immunology. 2024 Nov 1;13(11):e70005. doi: 10.1002/cti2.70005. eCollection 2024.
PubMed 39493859Tong Y, Ratnasiri K, Hanif S, Nguyen AT, Roh ME, Dorsey G, Kakuru A, Jagannathan P, Benjamin-Chung J. Intermittent preventive treatment for malaria in pregnancy and infant growth: a mediation analysis of a randomised trial. EBioMedicine. 2024 Nov;109:105397. doi: 10.1016/j.ebiom.2024.105397. Epub 2024 Oct 16.
PubMed 39418986Reyes RA, Turner L, Ssewanyana I, Jagannathan P, Feeney ME, Lavstsen T, Greenhouse B, Bol S, Bunnik EM. Differences in phenotype between long-lived memory B cells against Plasmodium falciparum merozoite antigens and variant surface antigens. PLoS Pathog. 2024 Oct 28;20(10):e1012661. doi: 10.1371/journal.ppat.1012661. eCollection 2024 Oct.
PubMed 39466842Nideffer J, Ty M, Donato M, John R, Kajubi R, Ji X, Nankya F, Musinguzi K, Press KD, Yang N, Camanag K, Greenhouse B, Kamya M, Feeney ME, Dorsey G, Utz PJ, Pulendran B, Khatri P, Jagannathan P. Clinical immunity to malaria involves epigenetic reprogramming of innate immune cells. PNAS Nexus. 2024 Aug 6;3(8):pgae325. doi: 10.1093/pnasnexus/pgae325. eCollection 2024 Aug.
PubMed 39161730Boyle MJ, Engwerda CR, Jagannathan P. The impact of Plasmodium-driven immunoregulatory networks on immunity to malaria. Nat Rev Immunol. 2024 Sep;24(9):637-653. doi: 10.1038/s41577-024-01041-5. Epub 2024 Jun 11.
PubMed 38862638Lee JJ, Kakuru A, Jacobson KB, Kamya MR, Kajubi R, Ranjit A, Gaw SL, Parsonnet J, Benjamin-Chung J, Dorsey G, Jagannathan P, Roh ME. Monthly Sulfadoxine-Pyrimethamine During Pregnancy Prevents Febrile Respiratory Illnesses: A Secondary Analysis of a Malaria Chemoprevention Trial in Uganda. Open Forum Infect Dis. 2024 Mar 13;11(4):ofae143. doi: 10.1093/ofid/ofae143. eCollection 2024 Apr.
PubMed 38585183Kakuru A, Jagannathan P. Can we reduce malaria in pregnancy and improve birth outcomes? Lancet. 2023 Mar 25;401(10381):973-975. doi: 10.1016/S0140-6736(23)00101-0. Epub 2023 Mar 10. No abstract available.
PubMed 36913960
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Immunity to Malaria in Young Children With Effective Chemoprevention
- ClinicalTrials.gov ID
- NCT04978272
- Acronym / sponsor ID
- MIC-DroP / MIC-DroP
- Conditions
- Malaria
- Keywords
- dihydroartemisinin-piperaquine, intermittent preventive therapy, children, immune response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 924 participants (actual)
- Lead sponsor
- Grant Dorsey, M.D, Ph.D.University, hospital or other
- Collaborators
- Stanford University, Infectious Diseases Research Collaboration, Uganda, National Institute of Allergy and Infectious Diseases (NIAID), Karolinska Institutet
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Double blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| IPTc DP 1 year | Active comparator | Drug: Dihydroartemisinin-piperaquine (DP), Other: DP PlaceboDP 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. |
| IPTc DP 2 years | Active comparator | Drug: Dihydroartemisinin-piperaquine (DP)DP given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up. |
| No IPTc | Placebo comparator | Other: DP PlaceboDP placebo given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up. |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
- Resident of Busia District
- Provision of informed consent by parent/guardian
- Agreement to present for any illness and avoid, where possible, medications outside the study protocol.
Key exclusion criteria (2 listed)
- Intention of moving outside Busia district during the study period
- Active medical problem requiring in-patient evaluation or chronic medical condition requiring frequent medical attention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dihydroartemisinin-piperaquine (DP)Also: Duo-CotecxinDuo-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. | Drug | IPTc DP 1 year, IPTc DP 2 years |
| DP PlaceboPlacebos will be identical appearance to DP. | Other | IPTc DP 1 year, No IPTc |
Primary outcome
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.
4 secondary outcomes
Incidence of complicated malaria
Time frame: 2 years to 4 years of age
Incidence of hospital admissions and/or deaths
Time frame: 2 years to 4 years of age
Prevalence of parasitemia
Time frame: 2 years to 4 years of age
Prevalence of anemia
Time frame: 2 years to 4 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 39026667Dobbs KR, Jagannathan P, Dechavanne C. Editorial: Immune tolerance and human malaria. Front Immunol. 2024 Jul 4;15:1450480. doi: 10.3389/fimmu.2024.1450480. eCollection 2024. No abstract available.
- Background: PubMed 36594472Nideffer J, Jagannathan P. Type I regulatory T cells in malaria: of mice and men. J Clin Invest. 2023 Jan 3;133(1):e166019. doi: 10.1172/JCI166019.
- Background: PubMed 34864925Hughes E, Wallender E, Kajubi R, Jagannathan P, Ochieng T, Kakuru A, Kamya MR, Clark TD, Rosenthal PJ, Dorsey G, Aweeka F, Savic RM. Piperaquine-Induced QTc Prolongation Decreases With Repeated Monthly Dihydroartemisinin-Piperaquine Dosing in Pregnant Ugandan Women. Clin Infect Dis. 2022 Aug 31;75(3):406-415. doi: 10.1093/cid/ciab965.
- Results publication: PubMed 40768597Li J, Wang X, Lackner AI, Narasimhan P, Li L, Mallajosyula V, Johnson MM, Hobler AL, Kirosingh AS, Braun AE, Nankya F, Musinguzi K, Kakuru A, Kamya M, Rosenthal PJ, Dorsey G, Jagannathan P, Angelo M, Pollheimer J, Gaw SL, Winn VD, Nadeau KC, Davis MM. Regulatory KIR+CD8+ T cells are elevated during human pregnancy. Sci Transl Med. 2025 Aug 6;17(810):eadm7697. doi: 10.1126/scitranslmed.adm7697. Epub 2025 Aug 6.
- Results publication: PubMed 39649586Roh ME, Gutman J, Murphy M, Hill J, Madanitsa M, Kakuru A, Barsosio HC, Kariuki S, Lusingu JPA, Mosha F, Kajubi R, Kamya MR, Mathanga D, Chinkhumba J, Laufer MK, Mlugu E, Kamuhabwa AAR, Aklillu E, Minzi O, Okoro RN, Geidam AD, Ohieku JD, Desai M, Jagannathan P, Dorsey G, Ter Kuile FO. Dihydroartemisinin-piperaquine versus sulfadoxine-pyrimethamine for intermittent preventive treatment of malaria in pregnancy: a systematic review and individual participant data meta-analysis. medRxiv [Preprint]. 2024 Nov 26:2024.11.23.24315401. doi: 10.1101/2024.11.23.24315401.
- Results publication: PubMed 39493859Tukwasibwe S, Lewis SN, Taremwa Y, van der Ploeg K, Press KD, Ty M, Namirimu Nankya F, Musinguzi K, Nansubuga E, Bach F, Chamai M, Okitwi M, Tumusiime G, Nakimuli A, Colucci F, Kamya MR, Nankabirwa JI, Arinaitwe E, Greenhouse B, Dorsey G, Rosenthal PJ, Ssewanyana I, Jagannathan P. Natural killer cell antibody-dependent cellular cytotoxicity to Plasmodium falciparum is impacted by cellular phenotypes, erythrocyte polymorphisms, parasite diversity and intensity of transmission. Clin Transl Immunology. 2024 Nov 1;13(11):e70005. doi: 10.1002/cti2.70005. eCollection 2024.
- Results publication: PubMed 39418986Tong Y, Ratnasiri K, Hanif S, Nguyen AT, Roh ME, Dorsey G, Kakuru A, Jagannathan P, Benjamin-Chung J. Intermittent preventive treatment for malaria in pregnancy and infant growth: a mediation analysis of a randomised trial. EBioMedicine. 2024 Nov;109:105397. doi: 10.1016/j.ebiom.2024.105397. Epub 2024 Oct 16.
- Results publication: PubMed 39466842Reyes RA, Turner L, Ssewanyana I, Jagannathan P, Feeney ME, Lavstsen T, Greenhouse B, Bol S, Bunnik EM. Differences in phenotype between long-lived memory B cells against Plasmodium falciparum merozoite antigens and variant surface antigens. PLoS Pathog. 2024 Oct 28;20(10):e1012661. doi: 10.1371/journal.ppat.1012661. eCollection 2024 Oct.
- Results publication: PubMed 39161730Nideffer J, Ty M, Donato M, John R, Kajubi R, Ji X, Nankya F, Musinguzi K, Press KD, Yang N, Camanag K, Greenhouse B, Kamya M, Feeney ME, Dorsey G, Utz PJ, Pulendran B, Khatri P, Jagannathan P. Clinical immunity to malaria involves epigenetic reprogramming of innate immune cells. PNAS Nexus. 2024 Aug 6;3(8):pgae325. doi: 10.1093/pnasnexus/pgae325. eCollection 2024 Aug.
- Results publication: PubMed 38862638Boyle MJ, Engwerda CR, Jagannathan P. The impact of Plasmodium-driven immunoregulatory networks on immunity to malaria. Nat Rev Immunol. 2024 Sep;24(9):637-653. doi: 10.1038/s41577-024-01041-5. Epub 2024 Jun 11.
- Results publication: PubMed 38585183Lee JJ, Kakuru A, Jacobson KB, Kamya MR, Kajubi R, Ranjit A, Gaw SL, Parsonnet J, Benjamin-Chung J, Dorsey G, Jagannathan P, Roh ME. Monthly Sulfadoxine-Pyrimethamine During Pregnancy Prevents Febrile Respiratory Illnesses: A Secondary Analysis of a Malaria Chemoprevention Trial in Uganda. Open Forum Infect Dis. 2024 Mar 13;11(4):ofae143. doi: 10.1093/ofid/ofae143. eCollection 2024 Apr.
- Results publication: PubMed 36913960Kakuru A, Jagannathan P. Can we reduce malaria in pregnancy and improve birth outcomes? Lancet. 2023 Mar 25;401(10381):973-975. doi: 10.1016/S0140-6736(23)00101-0. Epub 2023 Mar 10. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prasanna Jagannathan, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dihydroartemisinin-piperaquine (DP) in people with Malaria, run by Grant Dorsey, M.D, Ph.D. at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic malaria following cessation of IPTc (time frame: 2 years to 4 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04978272, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.