SwePub
Sök i LIBRIS databas

  Utökad sökning

WFRF:(Macuacua Salesio)
 

Sökning: WFRF:(Macuacua Salesio) > (2023) > Efficacy and safety...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00006704naa a2200649 4500
001oai:DiVA.org:uu-524332
003SwePub
008240301s2023 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-5243322 URI
0247 a https://doi.org/10.1136/bmjopen-2022-0652952 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Djimde, Moussau Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.4 aut
2451 0a 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 1b 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 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Infektionsmedicin0 (SwePub)302092 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Infectious Medicine0 (SwePub)302092 hsv//eng
650 7a MEDICIN OCH HÄLSOVETENSKAPx Hälsovetenskapx Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi0 (SwePub)303022 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Health Sciencesx Public Health, Global Health, Social Medicine and Epidemiology0 (SwePub)303022 hsv//eng
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Reproduktionsmedicin och gynekologi0 (SwePub)302202 hsv//swe
650 7a 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
7001 a Tshiongo, Japhet Kabaluu Univ Kinshasa, Dept Trop Med, Kinshasa, DEM REP CONGO.4 aut
7001 a Muhindo, Hypolite Mavokou Univ Kinshasa, Dept Trop Med, Fac Med, Kinshasa, DEM REP CONGO.4 aut
7001 a Tinto, Halidouu Inst Rech en Sci St e IRSS, Unite Rech Clin Nanoro, Nanoro, Burkina Faso.4 aut
7001 a Sevene, Esperancau Ctr Invest Saude Manhica, Manhica, Mozambique.;Univ Eduardo Mondlane, Maputo, Mozambique.4 aut
7001 a Traore, Maminatau Inst Rech Sci St IRSS, Unite Rech Clin Nanoro, Ouagadougou, Burkina Faso.4 aut
7001 a Vala, Anifau Ctr Invest Saude Manhica, Manhica, Mozambique.4 aut
7001 a Macuacua, Salesiou Ctr Invest Saude Manhica CISM, Maputo, Mozambique.4 aut
7001 a Kabore, Berengeru Inst Rech Sci St IRSS, Unite Rech Clin Nanoro, Ouagadougou, Burkina Faso.4 aut
7001 a Dabira, Edgard Dinibau London Sch Hyg & Trop Med, MRC Unit Gambia MRCG, London, England.4 aut
7001 a Erhart, Annetteu London Sch Hyg & Trop Med, MRC Unit Gambia MRCG, London, England.4 aut
7001 a Diakite, Hamadounu Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.4 aut
7001 a Keita, Mohamedu Univ Sci Tech & Technol Bamako, Fac Med Odontostomatol, Bamako, Mali.4 aut
7001 a Piqueras, Mireiau Inst Salud Global Barcelona, Barcelona, Spain.4 aut
7001 a González, Raquelu Inst Salud Global Barcelona, Barcelona, Spain.4 aut
7001 a Menendez, Clarau Inst Salud Global Barcelona, Barcelona, Spain.4 aut
7001 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
7001 a Sagara, Issakau Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.4 aut
7001 a Mens, Petrau Univ Amsterdam, Acad Med Ctr Univ Amsterdam AMC, Med Ctr, Amsterdam, Netherlands.4 aut
7001 a Schallig, Henku Univ Amsterdam, Acad Med Ctr Univ Amsterdam AMC, Med Ctr, Amsterdam, Netherlands.4 aut
7001 a D'Alessandro, Umbertou MRC Labs Gambia, Banjul, Gambia.4 aut
7001 a Kayentao, Kassoumu Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.4 aut
7102 a Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.b Univ Kinshasa, Dept Trop Med, Kinshasa, DEM REP CONGO.4 org
7730 t BMJ Opend : BMJ Publishing Group Ltdg 13:10q 13:10x 2044-6055
8564 u https://doi.org/10.1136/bmjopen-2022-065295y Fulltext
8564 u https://uu.diva-portal.org/smash/get/diva2:1842033/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-524332
8564 8u https://doi.org/10.1136/bmjopen-2022-065295

Hitta via bibliotek

  • BMJ Open (Sök värdpublikationen i LIBRIS)

Till lärosätets databas

Kungliga biblioteket hanterar dina personuppgifter i enlighet med EU:s dataskyddsförordning (2018), GDPR. Läs mer om hur det funkar här.
Så här hanterar KB dina uppgifter vid användning av denna tjänst.

 
pil uppåt Stäng

Kopiera och spara länken för att återkomma till aktuell vy