MSGERC |
ECMM |
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David R. Boulware (Co-Chair) Lillian Tugume Todd P. McCarty Caleb P. Skipper Radha Rajasingham Blyue Dai David B. Meya John R. Perfect |
Tihana Bicanic (Co-Chair) Rachel Wake Methee Chayakulkeeree Peter R. Williamson Graeme Meintjes Joseph N. Jarvis Thomas S. Harrison |
A working group of experienced cryptococcal meningitis clinical investigators, a biostatistician and a patient representative, was convened by the Mycoses Study Group (MSG) and European Confederation of Medical Mycology (ECMM) with the objective to develop consensus guidance for endpoint criteria for future clinical trials in the treatment and prevention of cryptococcosis. In total 15 members, with geographic and gender balance participated.
First, we conducted a comprehensive literature review of cryptococcal meningitis clinical trials published from 1979 to January 2024. We used the following MESH search terms in Pubmed: “meningitis, cryptococcal AND Clinical Trial {Publication Type}.” All completed trials that investigated anti-fungal regimens, HIV therapy initiation strategies and regimens to prevent cryptococcal relapse were included. Ongoing trials were excluded. We examined primary and secondary endpoints outlined in the manuscript and characterized the trials by sample size and trial phase. Literature review was conducted by three authors (RMW, TM, and LT).
Second, we utilized a Delphi technique to solicit opinions on the relative importance of endpoints in clinical trials for cryptococcal meningitis. We invited all authors of recent clinical trials