Safety and efficacy of pyronaridine-artesunate paediatric granules in the treatment of uncomplicated malaria in children: insights from randomized clinical trials and a real-world study.

"Declarations Ethics approval and consent to participateAll patients, or their parents/guardians, provided written informed consent, and children able to understand the study gave signed assent. Ethics approval for the individual studies was granted as follows. SP-C-003-05: Gabon, Ethics Committee of the International Foundation for the Albert Schweitzer Hospital in Lambaréné. SP-C-007-07: Burkina Faso, Comité national d’éthique, Ministère de la Santé—Ministère des enseignements secondaires supérieurs et de la recherche scientifique—Comité d’Ethique pour la recherche en Santé; Democratic Republic of Congo, Ministère de l’Enseignement Supérieur et Universitaire, Ecole de santé Publique, Comité d’Ethique Université de Kinshasa, faculté de Médecine; Côte d’Ivoire, Ministère de la Santé et de l’Hygiène Publique—Comité National d’Ethique des Sciences de la Vie et de la Santé (CNESVS); Kenya, Kenyatta National Hospital Ethic Committee; Mali, Ministère de l’Education Nationale, Comité Institutionnel d’Ethique de la Faculté de Médicine de Pharmacie et d’Odonto Stomatologie Université de Bamako; The Philippines, Research Institute for Tropical Medicine Institutional/Ethical Review Board; Gabon, Comité d’Ethique Régional Indépendant de Lambaréné (CERIL). SP-C-013-11: Mali, Faculté de Médicine de Pharmacie et d'Odonto Stomatologie; Burkina Faso, Ministère de la Santé/Ministère de la Recherche Scientifique et de l’Innovation; Guinea, Comité National d’Ethique pour la Recherche en Santé. SP-C-021-15: Cameroon, Comité National d’Ethique de la Recherche pour la Santé Humaine; Democratic Republic of Congo, Comité d’Ethique de l’Université Protestante au Congo; Gabon, Comité Nationale d’Ethique et de la Recherche Scientifique and Comité d’Ethique Institutionnel Albert Schweitzer Hospital, Lambaréné; Côte d’Ivoire, Comité Nationale d’Ethique et de la Recherche Scientifique and Comité National d’Ethique des Sciences de la Vie et de Santé; and Republic of Congo, Comité d'éthique institutionnel de la Fondation Congolaise pour la Recherche Médicale. Consent for publicationNot applicable. Competing interestsStephan Duparc, Isabelle Borghini-Fuhrer and Adam Aspinall are employees of Medicines for Malaria Venture. Sarah Arbe-Barnes and Robert Miller are employees of Artemida Pharma. Jangsik Shin is an employee of Shin Poong Pharm. Co. Ltd. Naomi Richardson is an employee of Magenta Communications Ltd. which received funds from Medicines for Malaria Venture associated with this study. Martina Wibberg is an employee of DATAMAP GmbH which received funds from Medicines for Malaria Venture associated with this study. Michael Ramharter, Abdoulaye Djimde and Lawrence Fleckenstein declare no conflict of interest. Competing interests Stephan Duparc, Isabelle Borghini-Fuhrer and Adam Aspinall are employees of Medicines for Malaria Venture. Sarah Arbe-Barnes and Robert Miller are employees of Artemida Pharma. Jangsik Shin is an employee of Shin Poong Pharm. Co. Ltd. Naomi Richardson is an employee of Magenta Communications Ltd. which received funds from Medicines for Malaria Venture associated with this study. Martina Wibberg is an employee of DATAMAP GmbH which received funds from Medicines for Malaria Venture associated with this study. Michael Ramharter, Abdoulaye Djimde and Lawrence Fleckenstein declare no conflict of interest."

"Funding Pyronaridine–artesunate is being developed as a collaboration between Medicines for Malaria Venture and Shin Poong Pharm. Co. Ltd. Authors from Medicines for Malaria Venture and Shin Poong Pharm. Co. Ltd. have contributed to this article. This work was supported, in whole or in part, by the Bill & Melinda Gates Foundation (Grant Number INV-007155/19-BMGF-006). Under the grant conditions of the Foundation, a Creative Commons Attribution 4.0 Generic License has already been assigned to the Author Accepted Manuscript version that might arise from this submission. The WANECAM study was mainly funded by the European and Developing Countries Clinical Trial Partnership, and co-funded by Medicines for Malaria Venture (MMV; Geneva, Switzerland), UK Medical Research Council, Swedish International Development Cooperation Agency, German Ministry for Education and Research, University Claude Bernard (Lyon, France), Malaria Research and Training Centre (Bamako, Mali), Centre National de Recherche et de Formation sur le Paludisme (Burkina Faso), Institut de Recherche en Sciences de la Santé. (Bobo-Dioulasso, Burkina Faso), and Centre National de Formation et de Recherche en Santé. Rurale (Guinea). CANTAM was supported by Shin-Poong Pharmaceutical Co. Ltd, Seoul, Korea, and Medicines for Malaria Venture, Geneva, Switzerland. MMV is funded by a number of donors including USAID, Bill and Melinda Gates Foundation, UK Department for International Development, Norwegian Agency for Development Cooperation, Irish Aid, Newcrest Mining Limited, Australian Aid, Swiss Agency for Development and Co-operation, and the Wellcome Trust. The Central Africa Network on Tuberculosis, HIV/AIDS and Malaria (CANTAM) is part of the EDCTP2 Program supported by the European Union under Grant agreement RegNet2015-1045."

"Trial registration Clinicaltrials.gov: SP-C-003-05: identifier NCT00331136; SP-C-007-07: identifier NCT0541385; SP-C-021-15: identifier NCT03201770. Pan African Clinical Trials Registry: SP-C-013-11: identifier PACTR201105000286876"