MalariaPhase 3NCT04336189
Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda
A Phase 3 study testing Sulfadoxine-pyrimethamine (SP) and Dihydroartemisinin-piperaquine (DP) in people with Malaria, run by Grant Dorsey, M.D, Ph.D. at 1 site in Uganda.
Trial summary
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) + dihydroartemisin-piperaquine (DP) will significantly reduce the risk of adverse birth outcomes compared to IPTp with SP alone or DP alone. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Sulfadoxine-pyrimethamine (SP) and Dihydroartemisinin-piperaquine (DP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,757 participants
- Where
- 1 siteUganda
- Study dates
- 28 Dec 2020to 28 Jul 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Viable singleton pregnancy confirmed by ultrasound
- Estimated gestational age between 12-20 weeks
- Confirmed to be HIV- uninfected by rapid test
- 16 years of age or older
- Residency within Busia District of Uganda
- Provision of informed consent
- Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol
- Willing to deliver in the hospital
Who cannot join
- History of serious adverse event to SP or DP
- Active medical problem requiring inpatient evaluation at the time of screening
- Intention of moving outside of Busia District Uganda
- Chronic medical condition requiring frequent medical attention
- Prior chemopreventive therapy or any other antimalarial therapy during this pregnancy
- Early or active labor (documented by cervical change with uterine contractions)
- Multiple pregnancies (i.e. twins/triplets)
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Infectious Diseases Research Collaboration Clinic - Masafu Hospital
Masafu, Busia
About this study
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) + dihydroartemisin-piperaquine (DP) will significantly reduce the risk of adverse birth outcomes compared to IPTp with SP alone or DP alone. This double-blinded randomized controlled phase III trial of 2757 HIV uninfected pregnant women enrolled at 12-20 weeks gestation will be randomized in equal proportions to one of three IPTp treatment arms: 1) SP given every 4 weeks, or 2) DP given every 4 weeks, or 3) SP+DP given every 4 weeks. SP or DP placebos will be used to ensure adequate blinding is achieved in the study and follow-up will end 28 days after giving birth.
Read the detailed description
Malaria in pregnancy remains a major challenge in Africa, where approximately 50 million women are at risk for P. falciparum infection during pregnancy each year. Among pregnant women living in malaria endemic areas symptomatic disease is uncommon, but infection with malaria parasites is associated with maternal anemia and adverse birth outcomes including abortions, stillbirth, preterm birth, low birth weight (LBW), and infant mortality. The World Health Organization (WHO) recommends the use of long-lasting insecticidal nets (LLINs) and intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) for the prevention of malaria in pregnancy in endemic areas of Africa. However, there is concern for diminishing efficacy of these interventions due to the spread of vector resistance to the pyrethroid insecticides used in LLINs and parasite resistance to SP. Thus, there is an urgent need for new strategies for the prevention of malaria in pregnancy and improving birth outcomes. Artemisinin-based combination therapies (ACTs) are now the standard treatment for malaria in Africa. Dihydroartemisin-piperaquine (DP) is a fixed-dose ACT and an attractive alternative to SP for IPTp. DP is highly efficacious, and the long half-life of piperaquine provides at least 4 weeks of post-treatment prophylaxis. Recent randomized controlled trials showed that, compared to IPTp with SP, IPTp with DP dramatically reduced risks of malaria-specific outcomes but there were minimal differences between the SP and DP groups in risks of adverse birth outcomes. The key question for this study is why IPTp with either SP or DP is associated with similar risks of adverse birth outcomes despite the far superior antimalarial activity of DP. The likely explanation is that SP, a broad-spectrum antibiotic, protects against non-malarial causes of LBW and preterm birth. The central hypothesis is that SP improves birth outcomes independent of its antimalarial activity and that IPTp with a combination of SP+DP will offer antimalarial and non-antimalarial benefits, thus providing superior prevention of adverse birth outcomes compared to either drug used alone. To test this hypothesis, a double-blinded randomized clinical trial will conducted in a rural area of Uganda with very high malaria transmission intensity, where there is already an established infrastructure for clinical research. Specific aims will be (1) to compare the risk of adverse birth outcomes among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP, (2) To compare safety and tolerability of IPTp regimens among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP, and (3) to compare risks of malaria-specific and non-malarial outcomes among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP. This study will be the first to evaluate the efficacy and safety of a novel combination of well-studied drugs for improving birth outcomes and findings may well have important policy implications, with a change in standard practice for millions of pregnant women in Africa.
- Conditions
- Malaria
- Being tested
- Sulfadoxine-pyrimethamine (SP), Dihydroartemisinin-piperaquine (DP)
- Keywords
- dihydroartemisinin-piperaquine, sulfadoxine-pyrimethamine, IPTp, reproductive tract infection, microbiome, drug resistance
- Medical subject headings
- Malaria, Reproductive Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine-pyrimethamine (SP)Drug
Also called Kamsidar
SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
Dihydroartemisinin-piperaquine (DP)Drug
Also called Duo-Cotecxin
DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| SP + DP placebo every 4 weeks | Active comparator | Not described Receives: Drug: Sulfadoxine-pyrimethamine (SP) |
| DP + SP placebo every 4 weeks | Active comparator | Not described Receives: Drug: Dihydroartemisinin-piperaquine (DP) |
| SP + DP given every 4 weeks | Active comparator | Not described Receives: Drug: Sulfadoxine-pyrimethamine (SP); Drug: Dihydroartemisinin-piperaquine (DP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Having a Composite Adverse Birth Outcome
Composite adverse birth outcome defined as the occurrence of any of the following:
- Spontaneous abortion: Fetal loss at < 28 weeks gestational age
- Stillbirth: Infant born deceased at > 28 weeks gestational age
- Low Birth Weight (LBW): Live birth with birth weight < 2500 gm
- Preterm birth: Live birth at < 37 weeks gestational age
- Small-for-gestational age (SGA): Live birth with weight-for-gestational age < 10th percentile of reference population
- Neonatal death: Live birth with neonatal death within the first 28 days of life
Measured: Time from first dose of study drugs up to 28 days postpartum, an average of 6 months
Incidence of Serious Adverse Events (SAE) Per Time at Risk
SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Time from first dose of study drugs up to 28 days postpartum, an average of 6 months
Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk
Grade 3 and 4 AEs or SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Time from first dose of study drugs up to 28 days postpartum, an average of 6 months
Secondary outcomes (23)
Number of Participants With Spontaneous Abortion
Spontaneous abortion defined as fetal loss at < 28 weeks gestational age
Measured: Time of delivery
Incidence of Anemia Adverse Event Per Time at Risk
Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Grade 3-4 AEs Possibly Related to Study Drugs
Grade 3-4 AEs possibly or definitely related to study drug defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Risk of Placental Malaria
Detection of malaria parasites or pigment by histopathology
Measured: At the time of delivery
Incidence of Malaria During Pregnancy
Episodes of symptomatic malaria (incidence per person year at risk following initiation of study drugs)
Measured: Day study drugs first given until delivery, an average of 6 months
Microscopic Parasitemia During Pregnancy
Proportion of routine samples with asexual parasites detected by microscopy
Measured: Day study drugs first given until delivery, an average of 6 months
Prevalence of Anemia During Pregnancy
Proportion of routine hemoglobin measurements < 11 g/dL
Measured: Day study drugs are first given until delivery
Stillbirth
Stillbirth defined as infant born deceased at > 28 weeks gestational age
Measured: Time of delivery
Low Birth Rate
Low birth weight defined as live birth with birth weight < 2500 gm
Measured: Time of delivery
Preterm Delivery
Preterm delivery defined as live birth at < 37 weeks gestational age
Measured: Time of delivery
Small-for-gestational Age
Small-for-gestational age defined as live birth with weight-for-gestational age < 10th percentile of reference population
Measured: Time of delivery
Neonatal Death
Neonatal death defined as live birth with neonatal death within the first 28 days of life
Measured: Time of delivery
Microscopic or Sub-microscopic Parasitemia During Pregnancy
Proportion of routine samples with asexual parasites detected by microscopy or qPCR
Measured: Day study drugs first given until delivery, an average of 6 months
Prevalence of Severe Anemia During Pregnancy
Proportion of routine hemoglobin measurements < 8 g/dL
Measured: Day study drugs are first given until delivery, an average of 6 months
Incidence of Stillbirth Adverse Event Per Time at Risk
Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Congenital Anomaly Adverse Event Per Time at Risk
Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Neutropenia Adverse Event Per Time at Risk
Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Proteinuria Adverse Event Per Time at Risk
Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Thrombocytopenia Adverse Event Per Time at Risk
Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Postpartum Hemorrhage Adverse Event Per Time at Risk
Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Pre-eclampsia Adverse Event Per Time at Risk
Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Preterm Birth <28 Gestational Age Adverse Event Per Time at Risk
Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Elevated Temperature Adverse Event Per Time at Risk
Grade 3-4 AEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Measured: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start28 Dec 2020
- Primary completion28 Jul 2024
- Study completion28 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- 2,757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grant Dorsey, M.D, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Infectious Diseases Research Collaboration, Uganda
- Responsible party
- Sponsor-investigator, Grant Dorsey, M.D, Ph.D., University of California, San Francisco
- Investigators
- Grant Dorsey, MD, PhD, Principal investigator, University of California, San FranciscoPhil Rosenthal, MD, Principal investigator, University of California, San FranciscoMoses Kamya, MBChB, MMed, PhD, Principal investigator, Makerere University; Infectious Diseases Research CollaborationAbel Kakuru, MBChB, PhD, Study director, Infectious Diseases Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336189
- Sponsor's protocol ID
- DPSP
- Status last verified
- Jun 2025
- First submitted
- 31 Mar 2020
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kakuru A, Kizza J, Aguti M, Adrama H, Ategeka J, Olwoch P, Nakalembe M, Nankabirwa JI, Opira B, Ozarslan N, Ranjit A, Dela Cruz E, Clark TD, Roh ME, Gaw SL, Jagannathan P, Rosenthal PJ, Kamya MR, Dorsey G. Dihydroartemisinin-piperaquine plus sulfadoxine-pyrimethamine versus either drug alone for intermittent preventive treatment of malaria in pregnancy: A double-blind, randomized, controlled phase 3 trial from Uganda. PLoS Med. 2025 Sep 18;22(9):e1004582. doi: 10.1371/journal.pmed.1004582. eCollection 2025 Sep.
PubMed 40966190
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda
- ClinicalTrials.gov ID
- NCT04336189
- Acronym / sponsor ID
- DPSP
- Conditions
- Malaria
- Keywords
- dihydroartemisinin-piperaquine, sulfadoxine-pyrimethamine, IPTp, reproductive tract infection, microbiome, drug resistance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,757 participants (actual)
- Lead sponsor
- Grant Dorsey, M.D, Ph.D.University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Infectious Diseases Research Collaboration, Uganda
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 28 Jul 2024 (actual)
- Study completion
- 28 Jul 2024 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) + dihydroartemisin-piperaquine (DP) will significantly reduce the risk of adverse birth outcomes compared to IPTp with SP alone or DP alone. This double-blinded randomized controlled phase III trial of 2757 HIV uninfected pregnant women enrolled at 12-20 weeks gestation will be randomized in equal proportions to one of three IPTp treatment arms: 1) SP given every 4 weeks, or 2) DP given every 4 weeks, or 3) SP+DP given every 4 weeks. SP or DP placebos will be used to ensure adequate blinding is achieved in the study and follow-up will end 28 days after giving birth.
Detailed description
Malaria in pregnancy remains a major challenge in Africa, where approximately 50 million women are at risk for P. falciparum infection during pregnancy each year. Among pregnant women living in malaria endemic areas symptomatic disease is uncommon, but infection with malaria parasites is associated with maternal anemia and adverse birth outcomes including abortions, stillbirth, preterm birth, low birth weight (LBW), and infant mortality. The World Health Organization (WHO) recommends the use of long-lasting insecticidal nets (LLINs) and intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) for the prevention of malaria in pregnancy in endemic areas of Africa. However, there is concern for diminishing efficacy of these interventions due to the spread of vector resistance to the pyrethroid insecticides used in LLINs and parasite resistance to SP. Thus, there is an urgent need for new strategies for the prevention of malaria in pregnancy and improving birth outcomes. Artemisinin-based combination therapies (ACTs) are now the standard treatment for malaria in Africa. Dihydroartemisin-piperaquine (DP) is a fixed-dose ACT and an attractive alternative to SP for IPTp. DP is highly efficacious, and the long half-life of piperaquine provides at least 4 weeks of post-treatment prophylaxis. Recent randomized controlled trials showed that, compared to IPTp with SP, IPTp with DP dramatically reduced risks of malaria-specific outcomes but there were minimal differences between the SP and DP groups in risks of adverse birth outcomes. The key question for this study is why IPTp with either SP or DP is associated with similar risks of adverse birth outcomes despite the far superior antimalarial activity of DP. The likely explanation is that SP, a broad-spectrum antibiotic, protects against non-malarial causes of LBW and preterm birth. The central hypothesis is that SP improves birth outcomes independent of its antimalarial activity and that IPTp with a combination of SP+DP will offer antimalarial and non-antimalarial benefits, thus providing superior prevention of adverse birth outcomes compared to either drug used alone. To test this hypothesis, a double-blinded randomized clinical trial will conducted in a rural area of Uganda with very high malaria transmission intensity, where there is already an established infrastructure for clinical research. Specific aims will be (1) to compare the risk of adverse birth outcomes among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP, (2) To compare safety and tolerability of IPTp regimens among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP, and (3) to compare risks of malaria-specific and non-malarial outcomes among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP. This study will be the first to evaluate the efficacy and safety of a novel combination of well-studied drugs for improving birth outcomes and findings may well have important policy implications, with a change in standard practice for millions of pregnant women in Africa.
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 |
|---|---|---|
| SP + DP placebo every 4 weeks | Active comparator | Drug: Sulfadoxine-pyrimethamine (SP) |
| DP + SP placebo every 4 weeks | Active comparator | Drug: Dihydroartemisinin-piperaquine (DP) |
| SP + DP given every 4 weeks | Active comparator | Drug: Sulfadoxine-pyrimethamine (SP), Drug: Dihydroartemisinin-piperaquine (DP) |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Viable singleton pregnancy confirmed by ultrasound
- Estimated gestational age between 12-20 weeks
- Confirmed to be HIV- uninfected by rapid test
- 16 years of age or older
- Residency within Busia District of Uganda
Key exclusion criteria (7 listed)
- History of serious adverse event to SP or DP
- Active medical problem requiring inpatient evaluation at the time of screening
- Intention of moving outside of Busia District Uganda
- Chronic medical condition requiring frequent medical attention
- Prior chemopreventive therapy or any other antimalarial therapy during this pregnancy
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 |
|---|---|---|
| Sulfadoxine-pyrimethamine (SP)Also: KamsidarSP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets. | Drug | SP + DP given every 4 weeks, SP + DP placebo every 4 weeks |
| Dihydroartemisinin-piperaquine (DP)Also: Duo-CotecxinDP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days. | Drug | DP + SP placebo every 4 weeks, SP + DP given every 4 weeks |
Primary outcome
Risk of Having a Composite Adverse Birth Outcome
Time frame: Time from first dose of study drugs up to 28 days postpartum, an average of 6 months
Composite adverse birth outcome defined as the occurrence of any of the following: * Spontaneous abortion: Fetal loss at < 28 weeks gestational age * Stillbirth: Infant born deceased at > 28 weeks gestational age * Low Birth Weight (LBW): Live birth with birth weight < 2500 gm * Preterm birth: Live birth at < 37 weeks gestational age * Small-for-gestational age (SGA): Live birth with weight-for-gestational age < 10th percentile of reference population * Neonatal death: Live birth with neonatal death within the first 28 days of life
Incidence of Serious Adverse Events (SAE) Per Time at Risk
Time frame: Time from first dose of study drugs up to 28 days postpartum, an average of 6 months
SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables
Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk
Time frame: Time from first dose of study drugs up to 28 days postpartum, an average of 6 months
Grade 3 and 4 AEs or SAEs as defined by the July 2017 NIH DAIDS Toxicity Tables
23 secondary outcomes
Number of Participants With Spontaneous Abortion
Time frame: Time of delivery
Incidence of Anemia Adverse Event Per Time at Risk
Time frame: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Grade 3-4 AEs Possibly Related to Study Drugs
Time frame: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Risk of Placental Malaria
Time frame: At the time of delivery
Incidence of Malaria During Pregnancy
Time frame: Day study drugs first given until delivery, an average of 6 months
Microscopic Parasitemia During Pregnancy
Time frame: Day study drugs first given until delivery, an average of 6 months
Prevalence of Anemia During Pregnancy
Time frame: Day study drugs are first given until delivery
Stillbirth
Time frame: Time of delivery
Low Birth Rate
Time frame: Time of delivery
Preterm Delivery
Time frame: Time of delivery
Small-for-gestational Age
Time frame: Time of delivery
Neonatal Death
Time frame: Time of delivery
Microscopic or Sub-microscopic Parasitemia During Pregnancy
Time frame: Day study drugs first given until delivery, an average of 6 months
Prevalence of Severe Anemia During Pregnancy
Time frame: Day study drugs are first given until delivery, an average of 6 months
Incidence of Stillbirth Adverse Event Per Time at Risk
Time frame: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Congenital Anomaly Adverse Event Per Time at Risk
Time frame: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Neutropenia Adverse Event Per Time at Risk
Time frame: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Proteinuria Adverse Event Per Time at Risk
Time frame: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Thrombocytopenia Adverse Event Per Time at Risk
Time frame: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Postpartum Hemorrhage Adverse Event Per Time at Risk
Time frame: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Pre-eclampsia Adverse Event Per Time at Risk
Time frame: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Preterm Birth <28 Gestational Age Adverse Event Per Time at Risk
Time frame: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Incidence of Elevated Temperature Adverse Event Per Time at Risk
Time frame: Day study drugs are first given until when study participants reach 28 days postpartum or early study termination, an average of 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40966190Kakuru A, Kizza J, Aguti M, Adrama H, Ategeka J, Olwoch P, Nakalembe M, Nankabirwa JI, Opira B, Ozarslan N, Ranjit A, Dela Cruz E, Clark TD, Roh ME, Gaw SL, Jagannathan P, Rosenthal PJ, Kamya MR, Dorsey G. Dihydroartemisinin-piperaquine plus sulfadoxine-pyrimethamine versus either drug alone for intermittent preventive treatment of malaria in pregnancy: A double-blind, randomized, controlled phase 3 trial from Uganda. PLoS Med. 2025 Sep 18;22(9):e1004582. doi: 10.1371/journal.pmed.1004582. eCollection 2025 Sep.
- Individual participant dataSharing planned: No
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
Grant Dorsey, MD, PhD principal investigator
University of California, San Francisco
Phil Rosenthal, MD principal investigator
University of California, San Francisco
Moses Kamya, MBChB, MMed, PhD principal investigator
Makerere University; Infectious Diseases Research Collaboration
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 Sulfadoxine-pyrimethamine (SP) and 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 6 Nov 2025. 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. 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?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Risk of Having a Composite Adverse Birth Outcome (time frame: Time from first dose of study drugs up to 28 days postpartum, an average of 6 months). The study lists 3 primary outcomes in all. 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 NCT04336189, which also lists 1 linked publication.
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 6 Nov 2025.