MalariaPhase 3SAPOTNCT05426434
Sulfadoxine-pyrimethamine Plus Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment in Pregnancy
A Phase 3 study testing Dihydroartemisinin-Piperaquine (DP) and Sulfadoxine pyrimethamine (SP) in people with Malaria and Malaria in Pregnancy, run by Menzies School of Health Research at 1 site in Papua New Guinea.
Trial summary
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) plus dihydroartemisinin-piperaquine (DP) significantly reduces the risk of malaria infection (primary outcome) and adverse birth outcomes (key secondary outcome) in an endemic area of Papua… 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, Malaria in Pregnancy, Pregnancy Related
- What is being tested?
- Dihydroartemisinin-Piperaquine (DP) and Sulfadoxine pyrimethamine (SP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,172 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- 31 Aug 2022to Dec 2025
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women between 12-26 weeks' gestation
- 16 years of age or older
- Viable singleton intrauterine pregnancy
- Permanent resident of the study area
- Willing to adhere to scheduled and unscheduled study visit procedures
- Willing to birth in a study clinic or hospital
- Able to provide written informed consent
Who cannot join
- Multiple pregnancy (i.e. twins/triplets)
- Known heart ailment or other chronic medical condition requiring frequent hospital care
- Active medical problem requiring inpatient evaluation at the time of screening
- Severe malformations or non-viable pregnancy if observed by ultrasound
- Antimalarial therapy in the prior two weeks
- Unable to provide written informed consent
Show all 9Show fewer
- Known allergy or contraindication to any of the study drugs
- Early or active labour
- Known HIV-positive status
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site
Papua New Guinea Institute of Medical Research
Madang, Madang Province, 511
About this study
Official title: Intermittent Preventive Treatment in Pregnancy With Sulfadoxine-pyrimethamine Plus Dihydroartemisinin-piperaquine to Prevent Malaria Infection and Reduce Adverse Pregnancy Outcomes in Papua New Guinea - a Randomised Controlled Trial
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) plus dihydroartemisinin-piperaquine (DP) significantly reduces the risk of malaria infection (primary outcome) and adverse birth outcomes (key secondary outcome) in an endemic area of Papua New Guinea (PNG), compared to IPTp with SP alone (the current standard of care).
To test this hypothesis a double-blinded, placebo-controlled, phase-III, superiority trial will individually randomize 1,172 HIV-uninfected pregnant women enrolled from 12-26 gestational weeks in equal proportions to one of two IPTp arms: 1) SP given every for weeks, or 2) SP+DP given every 4 weeks. 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
Plasmodium falciparum and P. vivax infections cause malaria, maternal anemia and interfere with the development of the fetus, thereby increasing the risks of adverse pregnancy outcomes such as miscarriage, stillbirth, premature birth, fetal growth restriction, low birth weight, and infant death. Infected pregnant women are frequently asymptomatic, and current point-of-care tests miss placental and low-density infections. Monthly intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is designed to clear asymptomatic infections and provide post-treatment prophylaxis. The World Health Organization recommends IPTp with SP and long-lasting insecticidal bed nets for the prevention of malaria in pregnancy in endemic areas of sub-Saharan Africa. However, the emergence and spread of high-grade parasite resistance to SP threatens to compromise this strategy. Dihydroartemisinin-piperaquine (DP) is a safe fixed-dose artemisinin-based combination therapy used for the management of uncomplicated P. falciparum and P. vivax malaria in pregnancy and has emerged as a potential candidate to replace SP for IPTp. In comparative trials conducted in high-transmission settings in sub-Saharan Africa IPTp with DP was safe and significantly reduced the risk of P. falciparum infection compared to IPTp with SP. IPTp with DP also reduced the risk of P. vivax parasitemia in Papua Indonesia when compared to a single screen and treat approach. However, DP's superior antimalarial efficacy in African studies did not translate to large reductions in adverse pregnancy outcomes in these trials. This suggests that SP, whilst failing as an antimalarial, may prevent adverse pregnancy events via potent non-malarial effects that are not inherent to DP. For example, SP may provide protection from pathogens other than malaria parasites that are directly or indirectly involved in the causation of adverse pregnancy outcomes.
Papua New Guinea (PNG) is characterized by moderate intensity co-transmission of P. falciparum and P. vivax and a high burden of adverse pregnancy outcomes. PNG is the only country outside of Africa that has a policy of IPTp with SP. However, P. vivax resistance to SP is now common, high-grade P. falciparum resistance to SP may be emerging, and DP could provide enhanced antimalarial protection. However, given the high burden of adverse pregnancy outcomes from malaria- and non-malaria related causes, simply replacing SP with DP for IPTp in PNG may not lead to a reduction in adverse birth outcomes. Instead, combining DP with SP for IPTp has the potential to substantially improve health outcomes by reducing the risk of malaria infection whilst harnessing the non-malaria-related benefits of SP.
A double-blinded randomized controlled clinical trial will (1) compare the risk of malaria infection among pregnant women randomized to receive monthly IPTp with SP vs. SP+DP; (2) compare the risk of adverse pregnancy outcomes among pregnant women randomized to receive monthly IPTp with SP vs. SP+DP; and (3) compare safety and tolerability of monthly IPTp with SP vs SP+DP. The findings of this trial may have important policy implications, and the evidence generated will inform practice for PNG and sub-Saharan Africa.
- Conditions
- Malaria, Malaria in Pregnancy, Pregnancy Related
- Being tested
- Dihydroartemisinin-Piperaquine (DP), Sulfadoxine pyrimethamine (SP)
- 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 D-Artepp
DP (D-Artepp) will be supplied by Fosun Pharma, China. DP will consist of three 40mg/320mg) tablets given once a day for three consecutive days
Sulfadoxine pyrimethamine (SP)Drug
Also called G-COSPE
SP (G-COSPE) will be supplied by Fosun Pharma, China. SP will be given as a single dose consisting of three 500mg/25mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| SP + DP placebo every 4 weeks | Active comparator | Control arm Receives: Drug: Sulfadoxine pyrimethamine (SP) |
| SP + DP given every 4 weeks | Experimental | Intervention arm Receives: Drug: Dihydroartemisinin-Piperaquine (DP); Drug: Sulfadoxine pyrimethamine (SP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria infection in pregnancy
'Malaria infection in pregnancy' is a composite outcome, defined as one or more episode of P. falciparum and/or P. vivax infection, detected by microscopy and/or qPCR in peripheral blood or placental blood, or P. falciparum and/or P. vivax infection, detected as active infection on placental histology. The surveillance period will run from two weeks after the first dose of the first monthly treatment up until and including delivery (numerator) in women who attend at least one scheduled or unscheduled visit during the surveillance period (denominator).
Proportion of women with 'malaria infection in pregnancy'
Measured: Starting two weeks after initial dose until and including delivery
Secondary outcomes (30)
Adverse pregnancy outcome
Composite adverse birth outcome is defined as the occurrence of any of the following:
- Spontaneous miscarriage: Fetal loss <28 weeks of gestational age
- Stillbirth: Infant born deceased at ≥28 weeks of gestational age
- Low birth weight (LBW): Live birth with birth weight <2,500 grams
- Preterm birth (PTB): Live birth <37 weeks gestational age
- Small-for-gestational age (SGA): Live birth with birth weight-for-gestational-age <10th percentile of the INTERGROWTH-21st reference
- Neonatal death: Live birth with neonatal death within the first 28 days of life
Prevalence of adverse pregnancy outcome
Measured: Time of delivery up to 28 days postpartum
Clinical malaria during pregnancy
Incidence of new episodes of fever or history of fever plus positive RDT confirmed by microscopy and/or qPCR during pregnancy
Measured: Starting two weeks after initial dose until and including delivery
Parasitemia during pregnancy
Proportion of samples with parasites detected in maternal peripheral blood samples by microscopy or qPCR
Measured: Starting two weeks after initial dose until and including delivery
Composite placental malaria detected by microscopy, qPCR or by histology
Prevalence of placental parasites by microscopy, qPCR, or placental histology
Measured: At time of delivery
Placental malaria detected by microscopy
Prevalence of parasites in placental blood by microscopy
Measured: At time of delivery
Placental malaria detected by qPCR
Prevalence of parasites in placental blood by qPCR
Measured: At time of delivery
Active placental malaria detected by histology
Prevalence of active infection (presence of parasites) on histology
Measured: At time of delivery
Past placental malaria detected by histology
Prevalence of past infection (pigment only) on histology
Measured: At time of delivery
Placental malaria detected by histology
Prevalence of placental infection (active or past) on histology
Measured: At time of delivery
Composite fetal loss and neonatal death
Prevalence of fetal loss (spontaneous miscarriage or stillbirth) and neonatal death
Measured: Time of delivery up to 28 days postpartum
Composite of SGA-LBW-PTB
Prevalence of small for gestational age, low birth weight, and preterm birth
Measured: At time of delivery
SGA
Prevalence of small for gestational age using the new Intergrowth-21st population reference's 10th centile
Measured: At time of delivery
LBW
Prevalence of low birth weight
Measured: At time of delivery
PTB
Prevalence of preterm birth
Measured: At time of delivery
Birth weight
Mean birthweight
Measured: At time of delivery
Neonatal length
Neonatal length
Measured: At time of delivery
Maternal nutritional status
Changes in maternal body mass index (BMI)
Measured: 8 months from randomisation
Maternal nutritional status
Changes in maternal mid-upper arm circumference (MUAC)
Measured: 6 months from randomisation
Maternal anemia during pregnancy and at delivery
Proportion of routine haemoglobin measurements <100 g/L
Measured: 6 months from randomisation
Maternal hemoglobin levels during pregnancy and at delivery
Mean hemoglobin (g/L) at the third trimester antenatal visit and at delivery
Measured: 6 months from randomisation
Congenital anemia
Prevalence of anaemia (Hb <130 g/L) from newborn cord blood
Measured: At delivery
Maternal gametocyte carriage during pregnancy and at delivery
Proportion of P. falciparum positive samples with gametocytes at the third trimester antenatal visit and at delivery, by light microscopy and RT-qPCR
Measured: 6 months from randomisation
Molecular markers of DP resistance
Proportion of parasite positive samples with molecular markers of DP resistance
Measured: 6 months from randomisation
Molecular markers of SP drug resistance
Proportion of parasite positive samples with molecular markers of SP resistance
Measured: 6 months from randomisation
Maternal mortality
he death of a woman while pregnant or within 42 days of the end of pregnancy, irrespective of the duration and site of the pregnancy, but not from accidental or incidental causes
Measured: 8 months from randomisation
Congenital malformations
Any visible external congenital abnormality on surface examination
Measured: 8 months from randomisation
Other SAEs and AEs
Incidence of AEs and SAEs
Measured: 8 months from randomisation
(History) of vomiting study drug
Prevalence of vomiting investigational product (IP) twice at the same IP administration visit
Measured: 6 months from randomisation
Dizziness
Prevalence of dizziness after a course of IP
Measured: 6 months from randomisation
Gastrointestinal complaints
Prevalence of gastrointestinal complaints after a course of IP
Measured: 6 months from randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start31 Aug 2022
- Primary completion31 Mar 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Model description
- Double blinded randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, University of Melbourne, Curtin University, Liverpool School of Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Holger Unger, PhD MBChB, Principal investigator, Menzies School of Health Research, Darwin, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426434
- Sponsor's protocol ID
- 2021-4107
- Acronym
- SAPOT
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2022
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Preventive Treatment in Pregnancy With Sulfadoxine-pyrimethamine Plus Dihydroartemisinin-piperaquine to Prevent Malaria Infection and Reduce Adverse Pregnancy Outcomes in Papua New Guinea - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05426434
- Acronym / sponsor ID
- SAPOT / 2021-4107
- Conditions
- Malaria, Malaria in Pregnancy, Pregnancy Related
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,172 participants (estimated)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, University of Melbourne, Curtin University, Liverpool School of Tropical Medicine
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jun 2022 (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.
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) plus dihydroartemisinin-piperaquine (DP) significantly reduces the risk of malaria infection (primary outcome) and adverse birth outcomes (key secondary outcome) in an endemic area of Papua New Guinea (PNG), compared to IPTp with SP alone (the current standard of care).
To test this hypothesis a double-blinded, placebo-controlled, phase-III, superiority trial will individually randomize 1,172 HIV-uninfected pregnant women enrolled from 12-26 gestational weeks in equal proportions to one of two IPTp arms: 1) SP given every for weeks, or 2) SP+DP given every 4 weeks. 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
Plasmodium falciparum and P. vivax infections cause malaria, maternal anemia and interfere with the development of the fetus, thereby increasing the risks of adverse pregnancy outcomes such as miscarriage, stillbirth, premature birth, fetal growth restriction, low birth weight, and infant death. Infected pregnant women are frequently asymptomatic, and current point-of-care tests miss placental and low-density infections. Monthly intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is designed to clear asymptomatic infections and provide post-treatment prophylaxis. The World Health Organization recommends IPTp with SP and long-lasting insecticidal bed nets for the prevention of malaria in pregnancy in endemic areas of sub-Saharan Africa. However, the emergence and spread of high-grade parasite resistance to SP threatens to compromise this strategy. Dihydroartemisinin-piperaquine (DP) is a safe fixed-dose artemisinin-based combination therapy used for the management of uncomplicated P. falciparum and P. vivax malaria in pregnancy and has emerged as a potential candidate to replace SP for IPTp. In comparative trials conducted in high-transmission settings in sub-Saharan Africa IPTp with DP was safe and significantly reduced the risk of P. falciparum infection compared to IPTp with SP. IPTp with DP also reduced the risk of P. vivax parasitemia in Papua Indonesia when compared to a single screen and treat approach. However, DP's superior antimalarial efficacy in African studies did not translate to large reductions in adverse pregnancy outcomes in these trials. This suggests that SP, whilst failing as an antimalarial, may prevent adverse pregnancy events via potent non-malarial effects that are not inherent to DP. For example, SP may provide protection from pathogens other than malaria parasites that are directly or indirectly involved in the causation of adverse pregnancy outcomes.
Papua New Guinea (PNG) is characterized by moderate intensity co-transmission of P. falciparum and P. vivax and a high burden of adverse pregnancy outcomes. PNG is the only country outside of Africa that has a policy of IPTp with SP. However, P. vivax resistance to SP is now common, high-grade P. falciparum resistance to SP may be emerging, and DP could provide enhanced antimalarial protection. However, given the high burden of adverse pregnancy outcomes from malaria- and non-malaria related causes, simply replacing SP with DP for IPTp in PNG may not lead to a reduction in adverse birth outcomes. Instead, combining DP with SP for IPTp has the potential to substantially improve health outcomes by reducing the risk of malaria infection whilst harnessing the non-malaria-related benefits of SP.
A double-blinded randomized controlled clinical trial will (1) compare the risk of malaria infection among pregnant women randomized to receive monthly IPTp with SP vs. SP+DP; (2) compare the risk of adverse pregnancy outcomes among pregnant women randomized to receive monthly IPTp with SP vs. SP+DP; and (3) compare safety and tolerability of monthly IPTp with SP vs SP+DP. The findings of this trial may have important policy implications, and the evidence generated will inform practice for PNG and sub-Saharan Africa.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| SP + DP placebo every 4 weeks | Active comparator | Drug: Sulfadoxine pyrimethamine (SP)Control arm |
| SP + DP given every 4 weeks | Experimental | Drug: Dihydroartemisinin-Piperaquine (DP), Drug: Sulfadoxine pyrimethamine (SP)Intervention arm |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant women between 12-26 weeks' gestation
- 16 years of age or older
- Viable singleton intrauterine pregnancy
- Permanent resident of the study area
- Willing to adhere to scheduled and unscheduled study visit procedures
Key exclusion criteria (9 listed)
- Multiple pregnancy (i.e. twins/triplets)
- Known heart ailment or other chronic medical condition requiring frequent hospital care
- Active medical problem requiring inpatient evaluation at the time of screening
- Severe malformations or non-viable pregnancy if observed by ultrasound
- Antimalarial therapy in the prior two weeks
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: D-ArteppDP (D-Artepp) will be supplied by Fosun Pharma, China. DP will consist of three 40mg/320mg) tablets given once a day for three consecutive days | Drug | SP + DP given every 4 weeks |
| Sulfadoxine pyrimethamine (SP)Also: G-COSPESP (G-COSPE) will be supplied by Fosun Pharma, China. SP will be given as a single dose consisting of three 500mg/25mg tablets. | Drug | SP + DP given every 4 weeks, SP + DP placebo every 4 weeks |
Primary outcome
Malaria infection in pregnancy
Time frame: Starting two weeks after initial dose until and including delivery
'Malaria infection in pregnancy' is a composite outcome, defined as one or more episode of P. falciparum and/or P. vivax infection, detected by microscopy and/or qPCR in peripheral blood or placental blood, or P. falciparum and/or P. vivax infection, detected as active infection on placental histology. The surveillance period will run from two weeks after the first dose of the first monthly treatment up until and including delivery (numerator) in women who attend at least one scheduled or unscheduled visit during the surveillance period (denominator). Proportion of women with 'malaria infection in pregnancy'
30 secondary outcomes
Adverse pregnancy outcome
Time frame: Time of delivery up to 28 days postpartum
Clinical malaria during pregnancy
Time frame: Starting two weeks after initial dose until and including delivery
Parasitemia during pregnancy
Time frame: Starting two weeks after initial dose until and including delivery
Composite placental malaria detected by microscopy, qPCR or by histology
Time frame: At time of delivery
Placental malaria detected by microscopy
Time frame: At time of delivery
Placental malaria detected by qPCR
Time frame: At time of delivery
Active placental malaria detected by histology
Time frame: At time of delivery
Past placental malaria detected by histology
Time frame: At time of delivery
Placental malaria detected by histology
Time frame: At time of delivery
Composite fetal loss and neonatal death
Time frame: Time of delivery up to 28 days postpartum
Composite of SGA-LBW-PTB
Time frame: At time of delivery
SGA
Time frame: At time of delivery
LBW
Time frame: At time of delivery
PTB
Time frame: At time of delivery
Birth weight
Time frame: At time of delivery
Neonatal length
Time frame: At time of delivery
Maternal nutritional status
Time frame: 8 months from randomisation
Maternal nutritional status
Time frame: 6 months from randomisation
Maternal anemia during pregnancy and at delivery
Time frame: 6 months from randomisation
Maternal hemoglobin levels during pregnancy and at delivery
Time frame: 6 months from randomisation
Congenital anemia
Time frame: At delivery
Maternal gametocyte carriage during pregnancy and at delivery
Time frame: 6 months from randomisation
Molecular markers of DP resistance
Time frame: 6 months from randomisation
Molecular markers of SP drug resistance
Time frame: 6 months from randomisation
Maternal mortality
Time frame: 8 months from randomisation
Congenital malformations
Time frame: 8 months from randomisation
Other SAEs and AEs
Time frame: 8 months from randomisation
(History) of vomiting study drug
Time frame: 6 months from randomisation
Dizziness
Time frame: 6 months from randomisation
Gastrointestinal complaints
Time frame: 6 months from randomisation
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 6 Jun 2025.
- 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.
Holger Unger, PhD MBChB principal investigator
Menzies School of Health Research, Darwin, Australia
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) and Sulfadoxine pyrimethamine (SP) in people with Malaria and Malaria in Pregnancy, run by Menzies School of Health Research at 1 site in Papua New Guinea.
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 7 inclusion and 9 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 6 Jun 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 Papua New Guinea. 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?
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?
Malaria infection in pregnancy (time frame: Starting two weeks after initial dose until and including delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2025.