a prospective, open-label, single-arm, phase 2–3, non-randomised study

Funding Information: DNDi received financial support for this work from the following donors: European and Developing Countries Clinical Trials Partnership Association programme supported by the European Union (through the grant RIA2017NCT-1846) ; the Portuguese Foundation for Science and Technology, Portugal; Medecins Sans Frontieres International; the Swiss Agency for Development and Cooperation, Switzerland; and the Department for International Development, UK. The findings and conclusions contained herein are those of the authors and do not necessarily reflect the positions or policies of the aforementioned funding bodies. Fexinidazole is a compound that originates from a historical predecessor of Sanofi and is jointly developed through a collaboration between DNDi and Sanofi. We thank the participants in this study, the nurses, laboratory technicians, and other staff members at the study siteswho cared for them, and the representatives of the sponsors who were involved in data gathering and analyses. We thank the data safety monitoring board members who gave us invaluable advice: Andrew Edielu (Uganda) , Lucille Blumberg (South Africa) , Francois Chappuis (Switzerland) , and Jean-Francois Etard (France) . We also extend our gratitude to Annah Kitibwa and Edgar Kigozi of the Medical and Molecular Laboratory, Makerere University, Kampala, Uganda, for quantitative PCR analysis, and technician Joses Dinanga of the Institut National de Recherche Biomedicale, DRC, for their support in training activities. We thank Fanny Schoose and Yasmin Khan of Cardiabase (Banook group) for their support in electrocardiogram handling and analysis; Mathieu Felices for support in electrocardiogram analysis and interpretation, and Sarah Lezzar for support in pharmacokinetic analysis and interpretation, both of PhinC Development; Pegah Maghdooni and Valerie Wauthier of the Societe Generale de Surveillance for their participation in dry blood spot sampling analysis; Nadine Vallomi and Chantal Raffy ofTheradis Pharma (pharmacokinetic and quantitative PCR logistics) ; Doris Arlt-Hilares of Medecins Sans Frontieres, Logistique for providing laboratory materials and consumables; and special thanks to Gaele Ducher (Veristat) for providing medical writing services funded by DNDi as well as Louise Burrows and Edith Magak (DNDi) for carefully editing the final manuscript. Publisher Copyright: © 2025 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

Publication Details

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Universidade Nova de Lisboa's Repository (Universidade Nova de Lisboa)
Published
2025-05-01
Primary Topic
Forensic Toxicology and Drug Analysis
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article

a prospective, open-label, single-arm, phase 2–3, non-randomised study

Universidade Nova de Lisboa's Repository (Universidade Nova de Lisboa)
Forensic Toxicology and Drug Analysis
article

a prospective, open-label, single-arm, phase 2–3, non-randomised study

article en

Abstract

Funding Information: DNDi received financial support for this work from the following donors: European and Developing Countries Clinical Trials Partnership Association programme supported by the European Union (through the grant RIA2017NCT-1846) ; the Portuguese Foundation for Science and Technology, Portugal; Medecins Sans Frontieres International; the Swiss Agency for Development and Cooperation, Switzerland; and the Department for International Development, UK. The findings and conclusions contained herein are those of the authors and do not necessarily reflect the positions or policies of the aforementioned funding bodies. Fexinidazole is a compound that originates from a historical predecessor of Sanofi and is jointly developed through a collaboration between DNDi and Sanofi. We thank the participants in this study, the nurses, laboratory technicians, and other staff members at the study siteswho cared for them, and the representatives of the sponsors who were involved in data gathering and analyses. We thank the data safety monitoring board members who gave us invaluable advice: Andrew Edielu (Uganda) , Lucille Blumberg (South Africa) , Francois Chappuis (Switzerland) , and Jean-Francois Etard (France) . We also extend our gratitude to Annah Kitibwa and Edgar Kigozi of the Medical and Molecular Laboratory, Makerere University, Kampala, Uganda, for quantitative PCR analysis, and technician Joses Dinanga of the Institut National de Recherche Biomedicale, DRC, for their support in training activities. We thank Fanny Schoose and Yasmin Khan of Cardiabase (Banook group) for their support in electrocardiogram handling and analysis; Mathieu Felices for support in electrocardiogram analysis and interpretation, and Sarah Lezzar for support in pharmacokinetic analysis and interpretation, both of PhinC Development; Pegah Maghdooni and Valerie Wauthier of the Societe Generale de Surveillance for their participation in dry blood spot sampling analysis; Nadine Vallomi and Chantal Raffy ofTheradis Pharma (pharmacokinetic and quantitative PCR logistics) ; Doris Arlt-Hilares of Medecins Sans Frontieres, Logistique for providing laboratory materials and consumables; and special thanks to Gaele Ducher (Veristat) for providing medical writing services funded by DNDi as well as Louise Burrows and Edith Magak (DNDi) for carefully editing the final manuscript. Publisher Copyright: © 2025 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

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a prospective, open-label, single-arm, phase 2–3, non-randomised study · Universidade Nova de Lisboa's Repository (Universidade Nova de Lisboa) (2025) | TGRS Research Map | TGRS