Cerebrospinal Fluid Early Fungicidal Activity as a Surrogate Endpoint for Cryptococcal Meningitis Survival in Clinical Trials

BACKGROUND: In cryptococcal meningitis phase 2 clinical trials, early fungicidal activity (EFA) of Cryptococcus clearance from cerebrospinal fluid (CSF) is used as a surrogate endpoint for all-cause mortality. The Food and Drug Administration allows for using surrogate endpoints for accelerated regu...

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Publicado en:Clin Infect Dis
Main Authors: Pullen, Matthew F, Hullsiek, Katherine Huppler, Rhein, Joshua, Musubire, Abdu K, Tugume, Lillian, Nuwagira, Edwin, Abassi, Mahsa, Ssebambulidde, Kenneth, Mpoza, Edward, Kiggundu, Ruben, Akampurira, Andrew, Nabeta, Henry W, Schutz, Charlotte, Evans, Emily E, Rajasingham, Radha, Skipper, Caleb P, Pastick, Katelyn A, Williams, Darlisha A, Morawski, Bozena M, Bangdiwala, Ananta S, Meintjes, Graeme, Muzoora, Conrad, Meya, David B, Boulware, David R
Formato: Artigo
Idioma:Inglês
Publicado: Oxford University Press 2020
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Online Only Articles
Acceso en liña:https://ncbi.nlm.nih.gov/pmc/articles/PMC7755087/
https://ncbi.nlm.nih.gov/pubmed/31912875
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1093/cid/ciaa016
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