Malaria in PregnancyPhase 3ULTRAPYRAPREGNCT04783051
Comparison of ISTp- PYRAMAX-US-RDT to IPTp-SP to Prevent Malaria in Pregnant Women in DRC (ULTRAPYRAPREG)
A Phase 3 study testing Sulfadoxine pyrimethamine and Pyramax in people with Malaria in Pregnancy, run by University of Kinshasa at 1 site in Democratic Republic of the Congo.
Trial summary
In endemic settings Plasmodium falciparum (Pf) can sequester in the placenta resulting in low peripheral parasitemia and false negative malaria diagnosis in pregnant women. Intermittent Preventive Treatment in pregnant women with Sulphadoxine-Pyrimethamine (IPTp-SP) is one of the World Health Organization's… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria in Pregnancy
- What is being tested?
- Sulfadoxine pyrimethamine and Pyramax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 6 May 2021to 22 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gestation ≥16 weeks;
- Age: ≥18 years;
- Residence within the health facility catchment area;
- Willing to adhere to study requirements and to deliver at the health facility.
- Willing to provide written informed consent; if the woman is illiterate, she can choose an impartial witness, not related to the study, to accompany her during the informant consent process and they will both sign the informed consent form
Who cannot join
- Known history of allergy to SP or to an ACT
- An ongoing antibioprophylaxis with cotrimoxazole,
- Current issue requiring hospital admission (including severe malaria as defined by WHO)
- Pregnancy at high risk
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Maternité Esengo
Kinshasa
About this study
Official title: Comparison of IST Using Ultra-sensitive Malaria Rapid Diagnostic Test and Pyronaridine - Artesunate - PYRAMAX®) to Standard IPT Sulfadoxine-pyrimethamine to Prevent Malaria in Pregnant Women Living in Endemic Areas
In endemic settings Plasmodium falciparum (Pf) can sequester in the placenta resulting in low peripheral parasitemia and false negative malaria diagnosis in pregnant women. Intermittent Preventive Treatment in pregnant women with Sulphadoxine-Pyrimethamine (IPTp-SP) is one of the World Health Organization's recommended malaria control strategies in sub-Saharan African countries. The strategy overcomes the risk of misdiagnosis of malaria in pregnant women by treating them all with SP according to predetermined schedules, but the strategy is now threatened by the spread of Plasmodium parasite resistant strains. As a necessary alternative, Intermittent Screening and Treatment in pregnancy (ISTp), aims on the monthly screening of pregnant women with a malaria rapid diagnostic test (RDT) and the treatment of positive cases with artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. The ISTp depends on the performance of the diagnostic tests, and the use of ultrasensitive RDTs (us-RDTs), which have a higher analytical sensitivity than conventional RDTs, should improve the efficacy of the strategy.
Unlike IPTp-SP, ISTp prevents overuse of antimalarials and thus limits drug pressure on malaria parasites. This advantage could be potentiated by using, for pregnant women, an ACT that is not yet used or should not be used in the field for other strata of the population. The recently approved new ACT combination, Pyronaridine - Artesunate (Pyramax®) is the ideal candidate for this purpose.
Read more
This study will compare the effects of the ISTp using an us-RDT and Pyramax® (ISTp-US-Py) with the standard IPTp-SP on maternal malaria indicators (malaria infection, parasite density), maternal anemia, spontaneous abortions or intrauterine deaths during pregnancy, fetal morbidity (preterm birth, low birth weight, small for gestational age) and neonatal mortality at delivery in both study groups through conducting a randomized clinical trial enrolling second trimester pregnant women in Maternité Esengo Health Center, located in Kisenso, Kinshasa, the Democratic Republic of the Congo (DRC), a malaria perennial transmission area.
The results generated from this study will be essential for the National Malaria Control Program in the selection and implementation of new malaria control policies and addresses the effectiveness of IPTp-SP decline among pregnant women in the DRC.
Read the detailed description
- Introduction Malaria is a threat for pregnant women and their offspring in endemic settings (1, 2). Plasmodium falciparum (Pf) can sequester in the placenta during pregnancy, resulting in low peripheral parasitemia. As a consequence, malaria diagnostic tests are often false negative in pregnant women who actually do have a Pf malaria infection (3, 4).
Intermittent Preventive Treatment in pregnant women with Sulfadoxine-Pyrimethamine (IPTp-SP) is one of the World Health Organization (WHO)'s recommended malaria control strategies in sub-Saharan African countries (2). The IPTp-SP strategy surmounts the potential misdiagnosis of malaria in pregnant women by treating them all with SP at pre-determined schedules during the antenatal care (ANC) visits. The efficacy of IPTp-SP is dose dependent and relies on ANC coverage. However, the spread of Plasmodium SP resistant strains now threatens the efficacy of the IPTp-SP and can lead to the proliferation of placental resistant parasites in pregnant women (5-9).
As an alternative for IPTp-SP, Intermittent Screening and Treatment in pregnancy (ISTp) may be considered as an option (10). ISTp comprises of monthly screening of pregnant women with a malaria RDT and treatment of positive cases with an artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. The ISTp depends on the performance of the diagnostic tests and the use of ultrasensitive RDTs (us-RDTs), which have a higher sensitivity than conventional RDTs (11, 12), can avoid false negative that would prevent the method from being effective.
Unlike IPTp-SP, ISTp prevents overuse of antimalarials and, thus, limits drug pressure on malaria parasites (10). This advantage could be potentiated by using an ACT that is not yet used or should not be used by the national malaria control for other strata of the population than pregnant women. Pyronaridine - Artesunate (Pyramax®), a newly approved antimalarial is the ideal candidate for this purpose in Democratic Republic of Congo (DRC). Pyramax®, approved for use in malaria endemic countries since 2015, is used in the field to treat malaria in children and adults (13). There is little information on the safety of Pyramax® during pregnancy, however, Pyronaridine unintentionally administered successfully treated at least 40 cases of malaria in late pregnancy (14) and, a review reported that ACTs, although Pyramax® was not included in, are generally very effective and well tolerated during the second and third trimesters (15).
The hypothesis of this study is that the ISTp using Pyramax® for the treatment and performed with the us-RDT (ISTp-US-Py) is non inferior than IPTp-SP for the prevention of maternal malaria (malaria infection, parasite density), maternal anemia, spontaneous abortions or intrauterine death during pregnancy, fetal morbidity (premature birth, low birth weight, small for gestational age) and neonatal mortality at childbirth.
- Conditions
- Malaria in Pregnancy
- Being tested
- Sulfadoxine pyrimethamine, Pyramax
- Keywords
- Malaria, Pregnancy, IPTp-SP, ISTp-Pyramax, Kinshasa, DR Congo
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine pyrimethamineDrug
Also called IPTp-SP
Intermittent Preventive Treatment in pregnant women with Sulfadoxine-Pyrimethamine
PyramaxDrug
Also called ISTp-US-Py
Intermittent screening using ultra-sensitive malaria Rapid Diagnostic test and treatment using Pyronaridine - Artesunate (PYRAMAX®)
| Study group | Role | What they receive |
|---|---|---|
| IPTp-SP | Active comparator | The IPTp-SP group will be pregnant women who will receive the standard regimen recommended by the Malaria National Control Program (MNCP) at week 16, 28, 32 and 36 of their pregnancy Receives: Drug: Sulfadoxine pyrimethamine |
| ISTp-US-Py | Experimental | The ISTp-US-Py group will comprise pregnant women who will be screened monthly from the beginning of the 2nd trimester with ultra-sensitive -RDT and who will be treated with Pyramax® if the test is positive Receives: Drug: Pyramax |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of asymptomatic malaria in the 2 study arms
Asymptomatic malaria is defined as the presence of Pf diagnosed by an us-RDT in the peripheral blood and a T°≤38°C
Measured: 6 months
The proportion symptomatic malaria in the 2 study arms
Symptomatic malaria is be defined as the presence of Pf diagnosed by an us-RDT in the peripheral blood and a T°≥38°C
Measured: 6 months
The proportion of parasitic densities in the 2 study arms
Parasite density is assessed by the quantification of Pf parasites in the peripheral blood of asymptomatic/symptomatic women by a thin blood smear examined by standard malaria microscopy
Measured: 6 months
The proportion of anemia in the 2 study arms
Anemia is defined as a level of hemoglobin (Hb) <10g/dl
Measured: 6 months
The incidence of spontaneous abortions or intrauterine deaths in the 2 study arms
Intrauterine death is defined to describe the death of the offspring in the uterus
Measured: 6 months
The proportion of fetal morbidities in the 2 study arms
Fetal morbidity is defined as any of the following: Preterm birth (birth before 37 weeks gestation) and low-birth-weight (birth weight under 2,500 grams)
Measured: 6 months
The proportion of the neonatal and early neonatal mortality of the offspring in the 2 study arms
The early neonatal mortality is defined as infant death at birth or within 7 days of life; And the neonatal mortality is defined as infant death within the first 28 days of life
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start6 May 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Malaria in PregnancyStudies 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
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kinshasa
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Novartis
- Responsible party
- Principal investigator, Vivi Maketa, University of Kinshasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783051
- Sponsor's protocol ID
- 226/CNES/BN//PMMF/2020
- Acronym
- ULTRAPYRAPREG
- Status last verified
- Nov 2022
- First submitted
- 27 Feb 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Document to be share: all IPD that underlie results in a publication
Publications
Nosten F, McGready R, Mutabingwa T. Case management of malaria in pregnancy. Lancet Infect Dis. 2007 Feb;7(2):118-25. doi: 10.1016/S1473-3099(07)70023-3.
PubMed 17251082WHO. Guidelines for the treatment of malaria. Third edition2015. 316 p
Anchang-Kimbi JK, Achidi EA, Nkegoum B, Sverremark-Ekstrom E, Troye-Blomberg M. Diagnostic comparison of malaria infection in peripheral blood, placental blood and placental biopsies in Cameroonian parturient women. Malar J. 2009 Jun 8;8:126. doi: 10.1186/1475-2875-8-126.
PubMed 19505312Matangila JR, Lufuluabo J, Ibalanky AL, Inocencio da Luz RA, Lutumba P, Van Geertruyden JP. Asymptomatic Plasmodium falciparum infection is associated with anaemia in pregnancy and can be more cost-effectively detected by rapid diagnostic test than by microscopy in Kinshasa, Democratic Republic of the Congo. Malar J. 2014 Apr 2;13:132. doi: 10.1186/1475-2875-13-132.
PubMed 24690179van Eijk AM, Hill J, Larsen DA, Webster J, Steketee RW, Eisele TP, ter Kuile FO. Coverage of intermittent preventive treatment and insecticide-treated nets for the control of malaria during pregnancy in sub-Saharan Africa: a synthesis and meta-analysis of national survey data, 2009-11. Lancet Infect Dis. 2013 Dec;13(12):1029-42. doi: 10.1016/S1473-3099(13)70199-3. Epub 2013 Sep 18.
PubMed 24054085WHO. World Malaria Report 2017. Geneva: World Health Organization; 2017
Harrington WE, Mutabingwa TK, Kabyemela E, Fried M, Duffy PE. Intermittent treatment to prevent pregnancy malaria does not confer benefit in an area of widespread drug resistance. Clin Infect Dis. 2011 Aug 1;53(3):224-30. doi: 10.1093/cid/cir376.
PubMed 21765070McGready R, White NJ, Nosten F. Parasitological efficacy of antimalarials in the treatment and prevention of falciparum malaria in pregnancy 1998 to 2009: a systematic review. BJOG. 2011 Jan;118(2):123-35. doi: 10.1111/j.1471-0528.2010.02810.x.
PubMed 21159117Cottrell G, Moussiliou A, Luty AJ, Cot M, Fievet N, Massougbodji A, Deloron P, Tuikue Ndam N. Submicroscopic Plasmodium falciparum Infections Are Associated With Maternal Anemia, Premature Births, and Low Birth Weight. Clin Infect Dis. 2015 May 15;60(10):1481-8. doi: 10.1093/cid/civ122. Epub 2015 Feb 18.
PubMed 25694651Esu E, Berens-Riha N, Pritsch M, Nwachuku N, Loescher T, Meremikwu M. Intermittent screening and treatment with artemether-lumefantrine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in pregnancy: a facility-based, open-label, non-inferiority trial in Nigeria. Malar J. 2018 Jul 6;17(1):251. doi: 10.1186/s12936-018-2394-2.
PubMed 29976228Das S, Jang IK, Barney B, Peck R, Rek JC, Arinaitwe E, Adrama H, Murphy M, Imwong M, Ling CL, Proux S, Haohankhunnatham W, Rist M, Seilie AM, Hanron A, Daza G, Chang M, Nakamura T, Kalnoky M, Labarre P, Murphy SC, McCarthy JS, Nosten F, Greenhouse B, Allauzen S, Domingo GJ. Performance of a High-Sensitivity Rapid Diagnostic Test for Plasmodium falciparum Malaria in Asymptomatic Individuals from Uganda and Myanmar and Naive Human Challenge Infections. Am J Trop Med Hyg. 2017 Nov;97(5):1540-1550. doi: 10.4269/ajtmh.17-0245. Epub 2017 Aug 18.
PubMed 28820709Vasquez AM, Medina AC, Tobon-Castano A, Posada M, Velez GJ, Campillo A, Gonzalez IJ, Ding X. Performance of a highly sensitive rapid diagnostic test (HS-RDT) for detecting malaria in peripheral and placental blood samples from pregnant women in Colombia. PLoS One. 2018 Aug 2;13(8):e0201769. doi: 10.1371/journal.pone.0201769. eCollection 2018.
PubMed 30071004Ayyoub A, Methaneethorn J, Ramharter M, Djimde AA, Tekete M, Duparc S, Borghini-Fuhrer I, Shin JS, Fleckenstein L. Population Pharmacokinetics of Pyronaridine in Pediatric Malaria Patients. Antimicrob Agents Chemother. 2015 Dec 14;60(3):1450-8. doi: 10.1128/AAC.02004-15.
PubMed 26666916Croft SL, Duparc S, Arbe-Barnes SJ, Craft JC, Shin CS, Fleckenstein L, Borghini-Fuhrer I, Rim HJ. Review of pyronaridine anti-malarial properties and product characteristics. Malar J. 2012 Aug 9;11:270. doi: 10.1186/1475-2875-11-270.
PubMed 22877082D'Alessandro U, Hill J, Tarning J, Pell C, Webster J, Gutman J, Sevene E. Treatment of uncomplicated and severe malaria during pregnancy. Lancet Infect Dis. 2018 Apr;18(4):e133-e146. doi: 10.1016/S1473-3099(18)30065-3. Epub 2018 Jan 31.
PubMed 29395998
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of IST Using Ultra-sensitive Malaria Rapid Diagnostic Test and Pyronaridine - Artesunate - PYRAMAX®) to Standard IPT Sulfadoxine-pyrimethamine to Prevent Malaria in Pregnant Women Living in Endemic Areas
- ClinicalTrials.gov ID
- NCT04783051
- Acronym / sponsor ID
- ULTRAPYRAPREG / 226/CNES/BN//PMMF/2020
- Conditions
- Malaria in Pregnancy
- Keywords
- Malaria, Pregnancy, IPTp-SP, ISTp-Pyramax, Kinshasa, DR Congo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of KinshasaUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Novartis
- Study start
- 6 May 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 4 Mar 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.
In endemic settings Plasmodium falciparum (Pf) can sequester in the placenta resulting in low peripheral parasitemia and false negative malaria diagnosis in pregnant women. Intermittent Preventive Treatment in pregnant women with Sulphadoxine-Pyrimethamine (IPTp-SP) is one of the World Health Organization's recommended malaria control strategies in sub-Saharan African countries. The strategy overcomes the risk of misdiagnosis of malaria in pregnant women by treating them all with SP according to predetermined schedules, but the strategy is now threatened by the spread of Plasmodium parasite resistant strains. As a necessary alternative, Intermittent Screening and Treatment in pregnancy (ISTp), aims on the monthly screening of pregnant women with a malaria rapid diagnostic test (RDT) and the treatment of positive cases with artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. The ISTp depends on the performance of the diagnostic tests, and the use of ultrasensitive RDTs (us-RDTs), which have a higher analytical sensitivity than conventional RDTs, should improve the efficacy of the strategy.
Unlike IPTp-SP, ISTp prevents overuse of antimalarials and thus limits drug pressure on malaria parasites. This advantage could be potentiated by using, for pregnant women, an ACT that is not yet used or should not be used in the field for other strata of the population. The recently approved new ACT combination, Pyronaridine - Artesunate (Pyramax®) is the ideal candidate for this purpose.
This study will compare the effects of the ISTp using an us-RDT and Pyramax® (ISTp-US-Py) with the standard IPTp-SP on maternal malaria indicators (malaria infection, parasite density), maternal anemia, spontaneous abortions or intrauterine deaths during pregnancy, fetal morbidity (preterm birth, low birth weight, small for gestational age) and neonatal mortality at delivery in both study groups through conducting a randomized clinical trial enrolling second trimester pregnant women in Maternité Esengo Health Center, located in Kisenso, Kinshasa, the Democratic Republic of the Congo (DRC), a malaria perennial transmission area.
The results generated from this study will be essential for the National Malaria Control Program in the selection and implementation of new malaria control policies and addresses the effectiveness of IPTp-SP decline among pregnant women in the DRC.
Detailed description
- Introduction Malaria is a threat for pregnant women and their offspring in endemic settings (1, 2). Plasmodium falciparum (Pf) can sequester in the placenta during pregnancy, resulting in low peripheral parasitemia. As a consequence, malaria diagnostic tests are often false negative in pregnant women who actually do have a Pf malaria infection (3, 4).
Intermittent Preventive Treatment in pregnant women with Sulfadoxine-Pyrimethamine (IPTp-SP) is one of the World Health Organization (WHO)'s recommended malaria control strategies in sub-Saharan African countries (2). The IPTp-SP strategy surmounts the potential misdiagnosis of malaria in pregnant women by treating them all with SP at pre-determined schedules during the antenatal care (ANC) visits. The efficacy of IPTp-SP is dose dependent and relies on ANC coverage. However, the spread of Plasmodium SP resistant strains now threatens the efficacy of the IPTp-SP and can lead to the proliferation of placental resistant parasites in pregnant women (5-9).
As an alternative for IPTp-SP, Intermittent Screening and Treatment in pregnancy (ISTp) may be considered as an option (10). ISTp comprises of monthly screening of pregnant women with a malaria RDT and treatment of positive cases with an artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. The ISTp depends on the performance of the diagnostic tests and the use of ultrasensitive RDTs (us-RDTs), which have a higher sensitivity than conventional RDTs (11, 12), can avoid false negative that would prevent the method from being effective.
Unlike IPTp-SP, ISTp prevents overuse of antimalarials and, thus, limits drug pressure on malaria parasites (10). This advantage could be potentiated by using an ACT that is not yet used or should not be used by the national malaria control for other strata of the population than pregnant women. Pyronaridine - Artesunate (Pyramax®), a newly approved antimalarial is the ideal candidate for this purpose in Democratic Republic of Congo (DRC). Pyramax®, approved for use in malaria endemic countries since 2015, is used in the field to treat malaria in children and adults (13). There is little information on the safety of Pyramax® during pregnancy, however, Pyronaridine unintentionally administered successfully treated at least 40 cases of malaria in late pregnancy (14) and, a review reported that ACTs, although Pyramax® was not included in, are generally very effective and well tolerated during the second and third trimesters (15).
The hypothesis of this study is that the ISTp using Pyramax® for the treatment and performed with the us-RDT (ISTp-US-Py) is non inferior than IPTp-SP for the prevention of maternal malaria (malaria infection, parasite density), maternal anemia, spontaneous abortions or intrauterine death during pregnancy, fetal morbidity (premature birth, low birth weight, small for gestational age) and neonatal mortality at childbirth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPTp-SP | Active comparator | Drug: Sulfadoxine pyrimethamineThe IPTp-SP group will be pregnant women who will receive the standard regimen recommended by the Malaria National Control Program (MNCP) at week 16, 28, 32 and 36 of their pregnancy |
| ISTp-US-Py | Experimental | Drug: PyramaxThe ISTp-US-Py group will comprise pregnant women who will be screened monthly from the beginning of the 2nd trimester with ultra-sensitive -RDT and who will be treated with Pyramax® if the test is positive |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gestation ≥16 weeks;
- Age: ≥18 years;
- Residence within the health facility catchment area;
- Willing to adhere to study requirements and to deliver at the health facility.
- Willing to provide written informed consent; if the woman is illiterate, she can choose an impartial witness, not related to the study, to accompany her during the informant consent process and they will both sign the informed consent form
Key exclusion criteria (4 listed)
- Known history of allergy to SP or to an ACT
- An ongoing antibioprophylaxis with cotrimoxazole,
- Current issue requiring hospital admission (including severe malaria as defined by WHO)
- Pregnancy at high risk
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 pyrimethamineAlso: IPTp-SPIntermittent Preventive Treatment in pregnant women with Sulfadoxine-Pyrimethamine | Drug | IPTp-SP |
| PyramaxAlso: ISTp-US-PyIntermittent screening using ultra-sensitive malaria Rapid Diagnostic test and treatment using Pyronaridine - Artesunate (PYRAMAX®) | Drug | ISTp-US-Py |
Primary outcome
The proportion of asymptomatic malaria in the 2 study arms
Time frame: 6 months
Asymptomatic malaria is defined as the presence of Pf diagnosed by an us-RDT in the peripheral blood and a T°≤38°C
The proportion symptomatic malaria in the 2 study arms
Time frame: 6 months
Symptomatic malaria is be defined as the presence of Pf diagnosed by an us-RDT in the peripheral blood and a T°≥38°C
The proportion of parasitic densities in the 2 study arms
Time frame: 6 months
Parasite density is assessed by the quantification of Pf parasites in the peripheral blood of asymptomatic/symptomatic women by a thin blood smear examined by standard malaria microscopy
The proportion of anemia in the 2 study arms
Time frame: 6 months
Anemia is defined as a level of hemoglobin (Hb) <10g/dl
The incidence of spontaneous abortions or intrauterine deaths in the 2 study arms
Time frame: 6 months
Intrauterine death is defined to describe the death of the offspring in the uterus
The proportion of fetal morbidities in the 2 study arms
Time frame: 6 months
Fetal morbidity is defined as any of the following: Preterm birth (birth before 37 weeks gestation) and low-birth-weight (birth weight under 2,500 grams)
The proportion of the neonatal and early neonatal mortality of the offspring in the 2 study arms
Time frame: 28 days
The early neonatal mortality is defined as infant death at birth or within 7 days of life; And the neonatal mortality is defined as infant death within the first 28 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 17251082Nosten F, McGready R, Mutabingwa T. Case management of malaria in pregnancy. Lancet Infect Dis. 2007 Feb;7(2):118-25. doi: 10.1016/S1473-3099(07)70023-3.
- BackgroundWHO. Guidelines for the treatment of malaria. Third edition2015. 316 p
- Background: PubMed 19505312Anchang-Kimbi JK, Achidi EA, Nkegoum B, Sverremark-Ekstrom E, Troye-Blomberg M. Diagnostic comparison of malaria infection in peripheral blood, placental blood and placental biopsies in Cameroonian parturient women. Malar J. 2009 Jun 8;8:126. doi: 10.1186/1475-2875-8-126.
- Background: PubMed 24690179Matangila JR, Lufuluabo J, Ibalanky AL, Inocencio da Luz RA, Lutumba P, Van Geertruyden JP. Asymptomatic Plasmodium falciparum infection is associated with anaemia in pregnancy and can be more cost-effectively detected by rapid diagnostic test than by microscopy in Kinshasa, Democratic Republic of the Congo. Malar J. 2014 Apr 2;13:132. doi: 10.1186/1475-2875-13-132.
- Background: PubMed 24054085van Eijk AM, Hill J, Larsen DA, Webster J, Steketee RW, Eisele TP, ter Kuile FO. Coverage of intermittent preventive treatment and insecticide-treated nets for the control of malaria during pregnancy in sub-Saharan Africa: a synthesis and meta-analysis of national survey data, 2009-11. Lancet Infect Dis. 2013 Dec;13(12):1029-42. doi: 10.1016/S1473-3099(13)70199-3. Epub 2013 Sep 18.
- BackgroundWHO. World Malaria Report 2017. Geneva: World Health Organization; 2017
- Background: PubMed 21765070Harrington WE, Mutabingwa TK, Kabyemela E, Fried M, Duffy PE. Intermittent treatment to prevent pregnancy malaria does not confer benefit in an area of widespread drug resistance. Clin Infect Dis. 2011 Aug 1;53(3):224-30. doi: 10.1093/cid/cir376.
- Background: PubMed 21159117McGready R, White NJ, Nosten F. Parasitological efficacy of antimalarials in the treatment and prevention of falciparum malaria in pregnancy 1998 to 2009: a systematic review. BJOG. 2011 Jan;118(2):123-35. doi: 10.1111/j.1471-0528.2010.02810.x.
- Background: PubMed 25694651Cottrell G, Moussiliou A, Luty AJ, Cot M, Fievet N, Massougbodji A, Deloron P, Tuikue Ndam N. Submicroscopic Plasmodium falciparum Infections Are Associated With Maternal Anemia, Premature Births, and Low Birth Weight. Clin Infect Dis. 2015 May 15;60(10):1481-8. doi: 10.1093/cid/civ122. Epub 2015 Feb 18.
- Background: PubMed 29976228Esu E, Berens-Riha N, Pritsch M, Nwachuku N, Loescher T, Meremikwu M. Intermittent screening and treatment with artemether-lumefantrine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in pregnancy: a facility-based, open-label, non-inferiority trial in Nigeria. Malar J. 2018 Jul 6;17(1):251. doi: 10.1186/s12936-018-2394-2.
- Background: PubMed 28820709Das S, Jang IK, Barney B, Peck R, Rek JC, Arinaitwe E, Adrama H, Murphy M, Imwong M, Ling CL, Proux S, Haohankhunnatham W, Rist M, Seilie AM, Hanron A, Daza G, Chang M, Nakamura T, Kalnoky M, Labarre P, Murphy SC, McCarthy JS, Nosten F, Greenhouse B, Allauzen S, Domingo GJ. Performance of a High-Sensitivity Rapid Diagnostic Test for Plasmodium falciparum Malaria in Asymptomatic Individuals from Uganda and Myanmar and Naive Human Challenge Infections. Am J Trop Med Hyg. 2017 Nov;97(5):1540-1550. doi: 10.4269/ajtmh.17-0245. Epub 2017 Aug 18.
- Background: PubMed 30071004Vasquez AM, Medina AC, Tobon-Castano A, Posada M, Velez GJ, Campillo A, Gonzalez IJ, Ding X. Performance of a highly sensitive rapid diagnostic test (HS-RDT) for detecting malaria in peripheral and placental blood samples from pregnant women in Colombia. PLoS One. 2018 Aug 2;13(8):e0201769. doi: 10.1371/journal.pone.0201769. eCollection 2018.
- The PYRAPREG projectLink provided by the sponsor.
- Clinical trials and operational research studies to optimise the use of products for poverty-related diseases in mothers, newborns, children and/or adolescentsLink provided by the sponsor.
- Pharmaceuticals R. FANSIDAR. brand of sulfadoxine and pyrimethamine TABLETS 1996Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Document to be share: all IPD that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Pyramax in people with Malaria in Pregnancy, run by University of Kinshasa at 1 site in Democratic Republic of the Congo.
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 5 inclusion and 4 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 4 Nov 2022. 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 Democratic Republic of the Congo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of asymptomatic malaria in the 2 study arms (time frame: 6 months). The study lists 7 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 NCT04783051, which also lists 18 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 4 Nov 2022.