Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREG
Abstract Background Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is an important malaria control strategy in sub-Saharan Africa. Indeed, it overcomes the risk of misdiagnosis due to low peripheral parasitemia during pregnancy by treating women with SP on...
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06884-8 |
| _version_ | 1811310905693044736 |
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| author | Vivi Maketa Japhet Kabalu Melissa Kabena Flory Luzolo Hypolite Muhindo-Mavoko Henk D. F. H. Schallig Kassoum Kayentao Petra F. Mens Pascal Lutumba Halidou Tinto |
| author_facet | Vivi Maketa Japhet Kabalu Melissa Kabena Flory Luzolo Hypolite Muhindo-Mavoko Henk D. F. H. Schallig Kassoum Kayentao Petra F. Mens Pascal Lutumba Halidou Tinto |
| author_sort | Vivi Maketa |
| collection | DOAJ |
| description | Abstract Background Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is an important malaria control strategy in sub-Saharan Africa. Indeed, it overcomes the risk of misdiagnosis due to low peripheral parasitemia during pregnancy by treating women with SP on predetermined schedules. However, over time, the spread of Plasmodium-resistant strains has threatened this strategy in many countries. As an alternative, the intermittent screening and treatment for pregnancy (ISTp) aims at a monthly screening of pregnant women, preferably by using very sensitive tests such as ultrasensitive rapid diagnostic tests (us-RDTs) and the treatment of positive cases with artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. Unlike IPTp-SP, ISTp prevents overuse of antimalarials limiting the drug pressure on parasites, an advantage which can be potentiated by using an ACT like pyronaridine-artesunate (Pyramax®) that is not yet used in pregnant women in the field. Methods This study aims to compare the non-inferiority of ISTp using us-RDTs and Pyramax® versus IPTp-SP on malaria in pregnancy through a randomized clinical trial performed in Kisenso, Kinshasa, the Democratic Republic of the Congo, a malaria perennial transmission area. Discussion The results will be essential for the National Malaria Control Program to update the malaria prevention policy in pregnant women in the Democratic Republic of the Congo. Trial registration ClinicalTrials.gov NCT04783051 |
| first_indexed | 2024-04-13T10:08:22Z |
| format | Article |
| id | doaj.art-40563c416d414bcc9f555ac82e78fed0 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T10:08:22Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-40563c416d414bcc9f555ac82e78fed02022-12-22T02:51:01ZengBMCTrials1745-62152022-11-0123111110.1186/s13063-022-06884-8Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREGVivi Maketa0Japhet Kabalu1Melissa Kabena2Flory Luzolo3Hypolite Muhindo-Mavoko4Henk D. F. H. Schallig5Kassoum Kayentao6Petra F. Mens7Pascal Lutumba8Halidou Tinto9Department of Tropical Medicine, University of Kinshasa (UNIKIN)Department of Tropical Medicine, University of Kinshasa (UNIKIN)Department of Tropical Medicine, University of Kinshasa (UNIKIN)Department of Tropical Medicine, University of Kinshasa (UNIKIN)Department of Tropical Medicine, University of Kinshasa (UNIKIN)Amsterdam University Medical Centres, Academic Medical Centre at the University of Amsterdam (AMC), Laboratory for Experimental Parasitology, Amsterdam Institute for Infection and ImmunologyMalaria Research and Training Center (MRTC), University of Sciences of Techniques and Technologies of Bamako (USTTB)Amsterdam University Medical Centres, Academic Medical Centre at the University of Amsterdam (AMC), Laboratory for Experimental Parasitology, Amsterdam Institute for Infection and ImmunologyDepartment of Tropical Medicine, University of Kinshasa (UNIKIN)Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-CRUN)Abstract Background Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is an important malaria control strategy in sub-Saharan Africa. Indeed, it overcomes the risk of misdiagnosis due to low peripheral parasitemia during pregnancy by treating women with SP on predetermined schedules. However, over time, the spread of Plasmodium-resistant strains has threatened this strategy in many countries. As an alternative, the intermittent screening and treatment for pregnancy (ISTp) aims at a monthly screening of pregnant women, preferably by using very sensitive tests such as ultrasensitive rapid diagnostic tests (us-RDTs) and the treatment of positive cases with artemisinin-based combination therapy (ACT) regardless of the presence of symptoms. Unlike IPTp-SP, ISTp prevents overuse of antimalarials limiting the drug pressure on parasites, an advantage which can be potentiated by using an ACT like pyronaridine-artesunate (Pyramax®) that is not yet used in pregnant women in the field. Methods This study aims to compare the non-inferiority of ISTp using us-RDTs and Pyramax® versus IPTp-SP on malaria in pregnancy through a randomized clinical trial performed in Kisenso, Kinshasa, the Democratic Republic of the Congo, a malaria perennial transmission area. Discussion The results will be essential for the National Malaria Control Program to update the malaria prevention policy in pregnant women in the Democratic Republic of the Congo. Trial registration ClinicalTrials.gov NCT04783051https://doi.org/10.1186/s13063-022-06884-8MalariaPregnancyIPTp-SPISTpMalaria indicatorsUltra-sensitive RDTs |
| spellingShingle | Vivi Maketa Japhet Kabalu Melissa Kabena Flory Luzolo Hypolite Muhindo-Mavoko Henk D. F. H. Schallig Kassoum Kayentao Petra F. Mens Pascal Lutumba Halidou Tinto Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREG Trials Malaria Pregnancy IPTp-SP ISTp Malaria indicators Ultra-sensitive RDTs |
| title | Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREG |
| title_full | Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREG |
| title_fullStr | Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREG |
| title_full_unstemmed | Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREG |
| title_short | Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREG |
| title_sort | comparison of intermittent screening using ultra sensitive malaria rapid diagnostic test and treatment using a newly registered antimalarial pyronaridine artesunate pyramax r to standard intermittent preventive treatment with sulfadoxine pyrimethamine for the prevention of malaria in pregnant women living in endemic areas ultrapyrapreg |
| topic | Malaria Pregnancy IPTp-SP ISTp Malaria indicators Ultra-sensitive RDTs |
| url | https://doi.org/10.1186/s13063-022-06884-8 |
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