Impact of the 2019 Food and Drug Administration Guidance for Uncomplicated Urinary Tract Infection on Treatment Response Rates: A Reanalysis of a Clinical Trial of Nitrofurantoin vs Fosfomycin.

Rebecca L GrantAndrea BüchlerWilliam FlightChun HuangDiogo FerrinhoSalim JanmohamedAruni MulgirigamaMaciek Godycki-CwirkoLeonard LeiboviciAngela HuttnerStephan Harbarth

Published in: Open forum infectious diseases (2023)

Applying current FDA guidance resulted in lower composite efficacy rates than clinical resolution alone as observed in the initial clinical trial. This may limit the ability to compare antibiotic treatment effects between historical and future clinical trials.

Keyphrases

clinical trial
urinary tract infection
drug administration
phase ii
open label
double blind
phase iii
study protocol
current status
risk assessment
combination therapy
human health
placebo controlled