2837. Impact of Regulatory Guidelines on Therapeutic, Clinical, and Microbiological Success Rates in Uncomplicated Urinary Tract Infection: Results from a Two Phase 3 Randomized Controlled Trials of Oral Gepotidacin (EAGLE-2 and EAGLE-3)

BACKGROUND: For noninferiority RCTs in uUTIs, the latest US Food and Drug Administration (FDA; 2019)/European Medicines Agency (EMA; 2018) guidance recommends a primary endpoint of therapeutic response (combined clinical and microbiologic response) with success defined by full symptom resolution plu...

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Detalles Bibliográficos
Autores principales: Wagenlehner, Florian, Perry, Caroline R, Hooton, Thomas M, Scangarella-Oman, Nicole E, Millns, Helen, Jarvis, Emily, Dennison, Jeremy, Sheets, Amanda, Janmohamed, Salim
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Abstract
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10677095/
http://dx.doi.org/10.1093/ofid/ofad500.2447

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10677095/
http://dx.doi.org/10.1093/ofid/ofad500.2447

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