Received: 16 August 2018
Accepted: 29 October 2018
First Online: 23 November 2018
Change Date: 14 January 2019
Change Type: Correction
Change Details: Following publication of the original article , we have been notified that one of the author names was listed incorrectly. Both incorrect and correct author names are presented below. The original publication has been corrected.
Ethics approval and consent to participate
: The Research Ethics Committee of the London School of Hygiene and Tropical Medicine (ref. 14,355) have approved the protocol. We will not begin recruitment at any of the African sites until local ethical approval has been obtained. Any further amendments will be submitted and approved by each ethics committee.Written informed consent to enter the trial and be randomised will be obtained from participants or, in the case of those lacking capacity to consent, from family/guardians/persons with legal responsibility (if appropriate and in keeping with national guidance and regulations). Consent will be obtained after explanation of the aims, methods, benefits and potential hazards of the trial, and before any trial-specific procedures are performed or any blood is taken for the trial. Patients with altered mental status who are unable to consent will be enrolled into the study if their next of kin gives informed consent or assent (in keeping with appropriate national guidance and regulations) on their behalf. As soon as the patient’s mental status improves consent will be obtained as above, with care taken to ensure they understand that they are free to withdraw from the study and if they do so this will not jeopardise their future care. Participants who withdraw will revert to the standard of care at the treatment site (usually amphotericin B deoxycholate and fluconazole daily for two weeks or fluconazole monotherapy for two weeks). It must be made completely and unambiguously clear that the participant (or guardian) is free to refuse to participate in all or any aspect of the trial, at any time and for any reason, without incurring any penalty or affecting their access to the standard treatment available at the recruiting site (or that of their relative). Separate consent forms will be completed for the storage and/or genetic analysis of samples as determined by local guidelines. Original signed consent forms will be kept by the investigator and documented in the eCRF, a copy given to the participant or family and a copy placed in the participant’s medical notes.
: Not applicable.
: JNJ and TSH were the recipients of a Gilead Investigator Initiated Award (completed). TSH has received speaker fees from Gilead Sciences and Pfizer.
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