Sökning: onr:"swepub:oai:DiVA.org:uu-524332" > Efficacy and safety...
Fältnamn | Indikatorer | Metadata |
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000 | 06704naa a2200649 4500 | |
001 | oai:DiVA.org:uu-524332 | |
003 | SwePub | |
008 | 240301s2023 | |||||||||||000 ||eng| | |
024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-5243322 URI |
024 | 7 | a https://doi.org/10.1136/bmjopen-2022-0652952 DOI |
040 | a (SwePub)uu | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a ref2 swepub-contenttype |
072 | 7 | a art2 swepub-publicationtype |
100 | 1 | a Djimde, Moussau Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.4 aut |
245 | 1 0 | a Efficacy and safety of pyronaridine-artesunate (PYRAMAX) for the treatment of P. falciparum uncomplicated malaria in African pregnant women (PYRAPREG) :b study protocol for a phase 3, non-inferiority, randomised open-label clinical trial |
264 | 1 | b BMJ Publishing Group Ltd,c 2023 |
338 | a electronic2 rdacarrier | |
520 | a Introduction Malaria infection during pregnancy increases the risk of low birth weight and infant mortality and should be prevented and treated. Artemisinin-based combination treatments are generally well tolerated, safe and effective; the most used being artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP). Pyronaridine-artesunate (PA) is a new artemisinin-based combination. The main objective of this study is to determine the efficacy and safety of PA versus AL or DP when administered to pregnant women with confirmed Plasmodium falciparum infection in the second or third trimester. The primary hypothesis is the pairwise non-inferiority of PA as compared with either AL or DP.Methods and analysis A phase 3, non-inferiority, randomised, open-label clinical trial to determine the safety and efficacy of AL, DP and PA in pregnant women with malaria in five sub-Saharan, malaria-endemic countries (Burkina Faso, Democratic Republic of the Congo, Mali, Mozambique and the Gambia). A total of 1875 pregnant women will be randomised to one of the treatment arms. Women will be actively monitored until Day 63 post-treatment, at delivery and 4–6 weeks after delivery, and infants’ health will be checked on their first birthday. The primary endpoint is the PCR-adjusted rate of adequate clinical and parasitological response at Day 42 in the per-protocol population.Ethics and dissemination This protocol has been approved by the Ethics Committee for Health Research in Burkina Faso, the National Health Ethics Committee in the Democratic Republic of Congo, the Ethics Committee of the Faculty of Medicine and Odontostomatology/Faculty of Pharmacy in Mali, the Gambia Government/MRCG Joint Ethics Committee and the National Bioethics Committee for Health in Mozambique. Written informed consent will be obtained from each individual prior to her participation in the study. The results will be published in peer-reviewed open access journals and presented at (inter)national conferences and meetings.Trial registration number PACTR202011812241529. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Infektionsmedicin0 (SwePub)302092 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Infectious Medicine0 (SwePub)302092 hsv//eng |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Hälsovetenskapx Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi0 (SwePub)303022 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Health Sciencesx Public Health, Global Health, Social Medicine and Epidemiology0 (SwePub)303022 hsv//eng |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Reproduktionsmedicin och gynekologi0 (SwePub)302202 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Obstetrics, Gynaecology and Reproductive Medicine0 (SwePub)302202 hsv//eng |
653 | a epidemiology | |
653 | a infection control | |
653 | a tropical medicine | |
653 | a parasitology | |
700 | 1 | a Tshiongo, Japhet Kabaluu Univ Kinshasa, Dept Trop Med, Kinshasa, DEM REP CONGO.4 aut |
700 | 1 | a Muhindo, Hypolite Mavokou Univ Kinshasa, Dept Trop Med, Fac Med, Kinshasa, DEM REP CONGO.4 aut |
700 | 1 | a Tinto, Halidouu Inst Rech en Sci St e IRSS, Unite Rech Clin Nanoro, Nanoro, Burkina Faso.4 aut |
700 | 1 | a Sevene, Esperancau Ctr Invest Saude Manhica, Manhica, Mozambique.;Univ Eduardo Mondlane, Maputo, Mozambique.4 aut |
700 | 1 | a Traore, Maminatau Inst Rech Sci St IRSS, Unite Rech Clin Nanoro, Ouagadougou, Burkina Faso.4 aut |
700 | 1 | a Vala, Anifau Ctr Invest Saude Manhica, Manhica, Mozambique.4 aut |
700 | 1 | a Macuacua, Salesiou Ctr Invest Saude Manhica CISM, Maputo, Mozambique.4 aut |
700 | 1 | a Kabore, Berengeru Inst Rech Sci St IRSS, Unite Rech Clin Nanoro, Ouagadougou, Burkina Faso.4 aut |
700 | 1 | a Dabira, Edgard Dinibau London Sch Hyg & Trop Med, MRC Unit Gambia MRCG, London, England.4 aut |
700 | 1 | a Erhart, Annetteu London Sch Hyg & Trop Med, MRC Unit Gambia MRCG, London, England.4 aut |
700 | 1 | a Diakite, Hamadounu Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.4 aut |
700 | 1 | a Keita, Mohamedu Univ Sci Tech & Technol Bamako, Fac Med Odontostomatol, Bamako, Mali.4 aut |
700 | 1 | a Piqueras, Mireiau Inst Salud Global Barcelona, Barcelona, Spain.4 aut |
700 | 1 | a González, Raquelu Inst Salud Global Barcelona, Barcelona, Spain.4 aut |
700 | 1 | a Menendez, Clarau Inst Salud Global Barcelona, Barcelona, Spain.4 aut |
700 | 1 | a Dorlo, Thomas P. C.,d 1983-u Uppsala universitet,Institutionen för farmaci,Antoni Van Leeuwenhoek Hosp, Netherlands Canc Inst, Amsterdam, Netherlands4 aut0 (Swepub:uu)thodo249 |
700 | 1 | a Sagara, Issakau Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.4 aut |
700 | 1 | a Mens, Petrau Univ Amsterdam, Acad Med Ctr Univ Amsterdam AMC, Med Ctr, Amsterdam, Netherlands.4 aut |
700 | 1 | a Schallig, Henku Univ Amsterdam, Acad Med Ctr Univ Amsterdam AMC, Med Ctr, Amsterdam, Netherlands.4 aut |
700 | 1 | a D'Alessandro, Umbertou MRC Labs Gambia, Banjul, Gambia.4 aut |
700 | 1 | a Kayentao, Kassoumu Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.4 aut |
710 | 2 | a Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.b Univ Kinshasa, Dept Trop Med, Kinshasa, DEM REP CONGO.4 org |
773 | 0 | t BMJ Opend : BMJ Publishing Group Ltdg 13:10q 13:10x 2044-6055 |
856 | 4 | u https://doi.org/10.1136/bmjopen-2022-065295y Fulltext |
856 | 4 | u https://uu.diva-portal.org/smash/get/diva2:1842033/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print |
856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-524332 |
856 | 4 8 | u https://doi.org/10.1136/bmjopen-2022-065295 |
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