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Sökning: WFRF:(Mens Petra) > (2023) > Efficacy and safety...

  • Djimde, MoussaUniv Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali. (författare)

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

  • Artikel/kapitelEngelska2023

Förlag, utgivningsår, omfång ...

  • BMJ Publishing Group Ltd,2023
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-524332
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-524332URI
  • https://doi.org/10.1136/bmjopen-2022-065295DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • 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.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Tshiongo, Japhet KabaluUniv Kinshasa, Dept Trop Med, Kinshasa, DEM REP CONGO. (författare)
  • Muhindo, Hypolite MavokoUniv Kinshasa, Dept Trop Med, Fac Med, Kinshasa, DEM REP CONGO. (författare)
  • Tinto, HalidouInst Rech en Sci St e IRSS, Unite Rech Clin Nanoro, Nanoro, Burkina Faso. (författare)
  • Sevene, EsperancaCtr Invest Saude Manhica, Manhica, Mozambique.;Univ Eduardo Mondlane, Maputo, Mozambique. (författare)
  • Traore, MaminataInst Rech Sci St IRSS, Unite Rech Clin Nanoro, Ouagadougou, Burkina Faso. (författare)
  • Vala, AnifaCtr Invest Saude Manhica, Manhica, Mozambique. (författare)
  • Macuacua, SalesioCtr Invest Saude Manhica CISM, Maputo, Mozambique. (författare)
  • Kabore, BerengerInst Rech Sci St IRSS, Unite Rech Clin Nanoro, Ouagadougou, Burkina Faso. (författare)
  • Dabira, Edgard DinibaLondon Sch Hyg & Trop Med, MRC Unit Gambia MRCG, London, England. (författare)
  • Erhart, AnnetteLondon Sch Hyg & Trop Med, MRC Unit Gambia MRCG, London, England. (författare)
  • Diakite, HamadounUniv Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali. (författare)
  • Keita, MohamedUniv Sci Tech & Technol Bamako, Fac Med Odontostomatol, Bamako, Mali. (författare)
  • Piqueras, MireiaInst Salud Global Barcelona, Barcelona, Spain. (författare)
  • González, RaquelInst Salud Global Barcelona, Barcelona, Spain. (författare)
  • Menendez, ClaraInst Salud Global Barcelona, Barcelona, Spain. (författare)
  • Dorlo, Thomas P. C.,1983-Uppsala universitet,Institutionen för farmaci,Antoni Van Leeuwenhoek Hosp, Netherlands Canc Inst, Amsterdam, Netherlands(Swepub:uu)thodo249 (författare)
  • Sagara, IssakaUniv Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali. (författare)
  • Mens, PetraUniv Amsterdam, Acad Med Ctr Univ Amsterdam AMC, Med Ctr, Amsterdam, Netherlands. (författare)
  • Schallig, HenkUniv Amsterdam, Acad Med Ctr Univ Amsterdam AMC, Med Ctr, Amsterdam, Netherlands. (författare)
  • D'Alessandro, UmbertoMRC Labs Gambia, Banjul, Gambia. (författare)
  • Kayentao, KassoumUniv Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali. (författare)
  • Univ Sci Tech & Technol Bamako, Malaria Res & Training Ctr, Bamako, Mali.Univ Kinshasa, Dept Trop Med, Kinshasa, DEM REP CONGO. (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:BMJ Open: BMJ Publishing Group Ltd13:102044-6055

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  • BMJ Open (Sök värdpublikationen i LIBRIS)

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