Verrest, Luka
Wasunna, Monique
Kokwaro, Gilbert
Aman, Rashid
Musa, Ahmed M.
Khalil, Eltahir A. G.
Mudawi, Mahmoud
Younis, Brima M.
Hailu, Asrat
Hurissa, Zewdu
Hailu, Workagegnehu
Tesfaye, Samson
Makonnen, Eyasu
Mekonnen, Yalemtsehay
Huitema, Alwin D. R.
Beijnen, Jos H.
Kshirsagar, Smita A.
Chakravarty, Jaya
Rai, Madhukar
Sundar, Shyam
Alves, Fabiana
Dorlo, Thomas P. C.
Funding for this research was provided by:
Médecins Sans Frontières
Drugs for Neglected Diseases initiative
Department for International Development
Médecins Sans Frontières/Doctors without Borders, International
Ministry of Foreign and European Affairs (MAEE), France; Region of Tuscany, Italy; République and Canton de Geneva, Switzerland
Medicor Foundation, Liechtenstein
Fondation Pro Victimis, Switzerland
Fondation André & Cyprien, Switzerland
Spanish Agency for International Development Cooperation (AECID), Spain
Swiss Agency for Development and Cooperation (SDC), Switzerland
Bill and Melinda Gates Foundation
Institute for OneWorld Health
Special Program for Research and Training in Tropical Diseases (TDR) of the United Nations Development Program
World Health Organization
Second European and Developing Countries Clinical Trials Partnership Programme (RIA2016S1635)
ZonMw/Dutch Research Council (91617140)
Article History
Accepted: 4 May 2021
First Online: 9 June 2021
Change Date: 6 September 2022
Change Type: Update
Change Details: Correct Open Access funding information has been updated in the Funding Note
Declarations
:
: Luka Verrest, Monique Wasunna, Gilbert Kokwaro, Rashid Aman, Ahmed M. Musa, Eltahir A.G. Khalil, Mahmoud Mudawi, Brima M. Younis, Asrat Hailu, Zewdu Hurissa, Workagegnehu Hailu, Samson Tesfaye, Eyasu Makonnen, Yalemtsehay Mekonnen, Alwin D.R. Huitema, Jos H. Beijnen, Smita A. Kshirsagar, Jaya Chakravarty, Madhukar Rai, Shyam Sundar, Fabiana Alves and Thomas P.C. Dorlo have no conflicts of interest to declare related to this study.
: The Eastern African clinical study was funded by Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases initiative (DNDi). The authors would like to thank the following donors for their support: Department for International Development (DFID), UK; Médecins Sans Frontières/Doctors without Borders, International; Ministry of Foreign and European Affairs (MAEE), France; Region of Tuscany, Italy; République and Canton de Geneva, Switzerland; Medicor Foundation, Liechtenstein; Fondation Pro Victimis, Switzerland; Fondation André and Cyprien, Switzerland; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; and private foundations and individual donors. The Indian clinical study was supported by the Bill and Melinda Gates Foundation, the Institute for One World Health, the Special Program for Research and Training in Tropical Diseases (TDR) of the United Nations Development Program, the World Bank, and the WHO. The current pharmacokinetic analysis was part of the EDCTP2 programme supported by the European Union (grant number RIA2016S1635-AfriKADIA). TPCD received funding from ZonMw/Dutch Research Council (NWO) [project number 91617140].
: The NONMEM control stream can be found in ESM 3. For availability of the datasets analysed during the current study, please contact the corresponding author.
: All procedures were conducted in accordance with the Declaration of Helsinki (2002 version) relating to the conduct of research on human subjects, and followed the International Committee on Harmonization guidelines for the conduct of clinical trials. The relevant Ethics Committees from each country approved the clinical studies. Patients or their legal guardians (if they were minors) provided signed informed consent prior to being randomized to the different treatment arms. In India, patients were randomly assigned to the pharmacokinetic substudy, while in Eastern Africa, patients were asked to participate in the pharmacokinetic substudy using a separate informed consent.
: All authors participated in the collection of the study data, interpretation of the study results, and drafting, critical revision and approval of the final version of the manuscript. LV, AH, FA, and TD were involved in the design of the analysis. LV and TD were responsible for data analysis and a draft of the first version of the manuscript.
: Not applicable.