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Efficacy and safety...
Efficacy and safety of pyronaridine-artesunate (PYRAMAX) for the treatment of P. falciparum uncomplicated malaria in African pregnant women (PYRAPREG) : study protocol for a phase 3, non-inferiority, randomised open-label clinical trial
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- Djimde, Moussa (author)
- Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.
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- Tshiongo, Japhet Kabalu (author)
- Univ Kinshasa, Dept Trop Med, Kinshasa, DEM REP CONGO.
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- Muhindo, Hypolite Mavoko (author)
- Univ Kinshasa, Dept Trop Med, Fac Med, Kinshasa, DEM REP CONGO.
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- Tinto, Halidou (author)
- Inst Rech en Sci St e IRSS, Unite Rech Clin Nanoro, Nanoro, Burkina Faso.
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- Sevene, Esperanca (author)
- Ctr Invest Saude Manhica, Manhica, Mozambique.;Univ Eduardo Mondlane, Maputo, Mozambique.
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- Traore, Maminata (author)
- Inst Rech Sci St IRSS, Unite Rech Clin Nanoro, Ouagadougou, Burkina Faso.
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- Vala, Anifa (author)
- Ctr Invest Saude Manhica, Manhica, Mozambique.
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- Macuacua, Salesio (author)
- Ctr Invest Saude Manhica CISM, Maputo, Mozambique.
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- Kabore, Berenger (author)
- Inst Rech Sci St IRSS, Unite Rech Clin Nanoro, Ouagadougou, Burkina Faso.
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- Dabira, Edgard Diniba (author)
- London Sch Hyg & Trop Med, MRC Unit Gambia MRCG, London, England.
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- Erhart, Annette (author)
- London Sch Hyg & Trop Med, MRC Unit Gambia MRCG, London, England.
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- Diakite, Hamadoun (author)
- Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.
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- Keita, Mohamed (author)
- Univ Sci Tech & Technol Bamako, Fac Med Odontostomatol, Bamako, Mali.
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- Piqueras, Mireia (author)
- Inst Salud Global Barcelona, Barcelona, Spain.
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- González, Raquel (author)
- Inst Salud Global Barcelona, Barcelona, Spain.
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- Menendez, Clara (author)
- Inst Salud Global Barcelona, Barcelona, Spain.
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- Dorlo, Thomas P. C., 1983- (author)
- Uppsala universitet,Institutionen för farmaci,Antoni Van Leeuwenhoek Hosp, Netherlands Canc Inst, Amsterdam, Netherlands
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- Sagara, Issaka (author)
- Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.
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- Mens, Petra (author)
- Univ Amsterdam, Acad Med Ctr Univ Amsterdam AMC, Med Ctr, Amsterdam, Netherlands.
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- Schallig, Henk (author)
- Univ Amsterdam, Acad Med Ctr Univ Amsterdam AMC, Med Ctr, Amsterdam, Netherlands.
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- D'Alessandro, Umberto (author)
- MRC Labs Gambia, Banjul, Gambia.
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- Kayentao, Kassoum (author)
- Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.
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Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali Univ Kinshasa, Dept Trop Med, Kinshasa, DEM REP CONGO. (creator_code:org_t)
- BMJ Publishing Group Ltd, 2023
- 2023
- English.
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In: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 13:10
- Related links:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)
Keyword
- epidemiology
- infection control
- tropical medicine
- parasitology
Publication and Content Type
- ref (subject category)
- art (subject category)
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Djimde, Moussa
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Tshiongo, Japhet ...
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Muhindo, Hypolit ...
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Tinto, Halidou
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Sevene, Esperanc ...
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Traore, Maminata
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Vala, Anifa
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Macuacua, Salesi ...
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Kabore, Berenger
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Dabira, Edgard D ...
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Erhart, Annette
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Diakite, Hamadou ...
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Keita, Mohamed
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Piqueras, Mireia
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González, Raquel
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Menendez, Clara
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Dorlo, Thomas P. ...
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Sagara, Issaka
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Mens, Petra
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Schallig, Henk
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D'Alessandro, Um ...
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Kayentao, Kassou ...
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Uppsala University