{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,28]],"date-time":"2026-01-28T13:27:02Z","timestamp":1769606822325,"version":"3.49.0"},"reference-count":13,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2023,10,8]],"date-time":"2023-10-08T00:00:00Z","timestamp":1696723200000},"content-version":"unspecified","delay-in-days":7,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001713","name":"European and Developing Countries Clinical Trials Partnership","doi-asserted-by":"publisher","award":["RIA2017MC-2025"],"award-info":[{"award-number":["RIA2017MC-2025"]}],"id":[{"id":"10.13039\/501100001713","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,8,31]]},"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      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\n                      <jats:italic>Plasmodium falciparum<\/jats:italic>\n                      infection in the second or third trimester. The primary hypothesis is the pairwise non-inferiority of PA as compared with either AL or DP.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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\u20136 weeks after delivery, and infants\u2019 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>PACTR202011812241529.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-065295","type":"journal-article","created":{"date-parts":[[2023,10,9]],"date-time":"2023-10-09T13:06:47Z","timestamp":1696856807000},"page":"e065295","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":10,"title":["Efficacy and safety of pyronaridine-artesunate (PYRAMAX) for the treatment of\n                    <i>P. falciparum<\/i>\n                    uncomplicated malaria in African pregnant women (PYRAPREG): study protocol for a phase 3, non-inferiority, randomised open-label clinical trial"],"prefix":"10.1136","volume":"13","author":[{"given":"Moussa","family":"Djimde","sequence":"first","affiliation":[{"name":"Malaria Research and Training Center, University of Sciences Techniques and Technologies of Bamako, Bamako, Mali"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2344-1111","authenticated-orcid":false,"given":"Japhet Kabalu","family":"Tshiongo","sequence":"additional","affiliation":[{"name":"D\u00e9partement of Tropical M\u00e9decine, Universite de Kinshasa, Kinshasa, Democratic Republic of Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hypolite Mavoko","family":"Muhindo","sequence":"additional","affiliation":[{"name":"Department of Tropical Medicine, Universite de Kinshasa Faculte de Medecine, Kinshasa, Democratic Republic of Congo"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Halidou","family":"Tinto","sequence":"additional","affiliation":[{"name":"Institut de 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