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Clinical Trial NCT05426434 (SAPOT) for Malaria, Malaria in Pregnancy, Pregnancy Related is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Sulfadoxine-pyrimethamine Plus Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment in Pregnancy (SAPOT) Phase 3 1,172 Double-Blind Placebo-Controlled Pregnancy Preventive
Clinical Trial NCT05426434 (SAPOT) is designed to study Prevention for Malaria, Malaria in Pregnancy, Pregnancy Related. It is a Phase 3 interventional study that is active, not recruiting, having started on 31 August 2022, with plans to enroll 1,172 participants. Led by Menzies School of Health Research, it is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 6 June 2025.
Brief 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 New Guinea (PNG), compared to IPTp with SP alone (the current standard of care).
To test this hypothes...
Show MoreDetailed 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 infecti...Show More
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
Conditions
MalariaMalaria in PregnancyPregnancy RelatedOther Study IDs
- SAPOT
- 2021-4107
NCT ID Number
Start Date (Actual)
2022-08-31
Last Update Posted
2025-06-06
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
1,172
Study Type
Interventional
PHASE
Phase 3
Status
Active, not recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorSP + DP placebo every 4 weeks Control arm | Sulfadoxine pyrimethamine (SP) SP (G-COSPE) will be supplied by Fosun Pharma, China. SP will be given as a single dose consisting of three 500mg/25mg tablets. |
ExperimentalSP + DP given every 4 weeks Intervention arm | Dihydroartemisinin-Piperaquine (DP) 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) SP (G-COSPE) will be supplied by Fosun Pharma, China. SP will be given as a single dose consisting of three 500mg/25mg tablets. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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' | Starting two weeks after initial dose until and including delivery |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 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 | 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 | 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 | At time of delivery |
Placental malaria detected by microscopy | Prevalence of parasites in placental blood by microscopy | At time of delivery |
Placental malaria detected by qPCR | Prevalence of parasites in placental blood by qPCR | At time of delivery |
Active placental malaria detected by histology | Prevalence of active infection (presence of parasites) on histology | At time of delivery |
Past placental malaria detected by histology | Prevalence of past infection (pigment only) on histology | At time of delivery |
Placental malaria detected by histology | Prevalence of placental infection (active or past) on histology | At time of delivery |
Composite fetal loss and neonatal death | Prevalence of fetal loss (spontaneous miscarriage or stillbirth) and neonatal death | 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 | At time of delivery |
SGA | Prevalence of small for gestational age using the new Intergrowth-21st population reference's 10th centile | At time of delivery |
LBW | Prevalence of low birth weight | At time of delivery |
PTB | Prevalence of preterm birth | At time of delivery |
Birth weight | Mean birthweight | At time of delivery |
Neonatal length | Neonatal length | At time of delivery |
Maternal nutritional status | Changes in maternal body mass index (BMI) | 8 months from randomisation |
Maternal nutritional status | Changes in maternal mid-upper arm circumference (MUAC) | 6 months from randomisation |
Maternal anemia during pregnancy and at delivery | Proportion of routine haemoglobin measurements \<100 g/L | 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 | 6 months from randomisation |
Congenital anemia | Prevalence of anaemia (Hb \<130 g/L) from newborn cord blood | 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 | 6 months from randomisation |
Molecular markers of DP resistance | Proportion of parasite positive samples with molecular markers of DP resistance | 6 months from randomisation |
Molecular markers of SP drug resistance | Proportion of parasite positive samples with molecular markers of SP resistance | 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 | 8 months from randomisation |
Congenital malformations | Any visible external congenital abnormality on surface examination | 8 months from randomisation |
Other SAEs and AEs | Incidence of AEs and SAEs | 8 months from randomisation |
(History) of vomiting study drug | Prevalence of vomiting investigational product (IP) twice at the same IP administration visit | 6 months from randomisation |
Dizziness | Prevalence of dizziness after a course of IP | 6 months from randomisation |
Gastrointestinal complaints | Prevalence of gastrointestinal complaints after a course of IP | 6 months from randomisation |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
16 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
- 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
- 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
- Known allergy or contraindication to any of the study drugs
- Early or active labour
- Known HIV-positive status
Menzies School of Health ResearchNo contact data.
1 Study Locations in 1 Countries
Madang Province
Papua New Guinea Institute of Medical Research, Madang, Madang Province, 511, Papua New Guinea