Document is current

Article History

Received: 1 February 2022

Accepted: 9 June 2022

First Online: 8 July 2022

Declarations

:

: The trial will be conducted in compliance with this study protocol. The study will be conducted according to Good Clinical Practice (Declaration of Helsinki and International Conference on Harmonization Guidelines) [CitationRef removed, CitationRef removed]. Ethical approval was obtained from the<i> “Comité National d’Ethique pour la Recherche en Santé”</i>, which is the ethics committee/institutional review board (EC/IRB) in Benin. Reference number is 122/MS/DC/SGM/CNERS/ST, on 25/10/2021. Should important protocol changes occur, they would be communicated in writing to the EC in Benin.Informed written consent to participate will be obtained from all participants. Participants who voluntarily agree to enroll in the study will be asked to document their informed consent. Inclusion in the study will occur only if the subject (for adults) or the parent/guardian (children > 11 years old are required to provide assent in Benin) gives written informed consent. It is the responsibility of the investigators or health care worker designee to obtain written informed consent from each individual participating in the study, after adequate presentation of aims, methods, anticipated benefits, and potential hazards of the study and giving the opportunity to ask questions. The written informed consent will be in French. If needed, the person will be given time to discuss the information received with members of the community or family before deciding to consent. The subject or parent/guardian will be asked to provide written and signed consent. If the subject is illiterate or unable to write, a fingerprint will be used. It is also the responsibility of the site PI to obtain the assent of children (> 11 years old), but their assent must be completed by the permission of a parent or guardian.In addition, two different sections will be included for obtaining separate informed consent for two additional sub-studies: one for the PK analysis and another one for the bacterial clearance study, being a nested informed consent.

: Not applicable.

: JA, LO, GV, NB, and FC hold stocks and are employees by the GSK group of companies. The authors declare that they have no competing interests. GSK is independent of the Tres Cantos Open Lab Foundation which is overseen by a governing board (TCOLF ExternalRef removed). The opinions expressed in this article are those of the authors and do not necessarily reflect the views of their employers.