Complicated Urinary Tract Infection Clinical Trial
Official title:
Efficacy of Intravenous Fosfomycin in the Treatment of Complicated Urinary in Real-life Conditions. Impact of the CMI and Baseline Mutations. FOSFO-MIC Project
This will be a prospective observational multicentre study in real-life conditions of
patients with complicated urinary infection of community presentation caused by Escherichia
coli using intravenous fosfomycin, quinolones or beta-lactams.
It's a multicenter and multinational study and it will include 200 patients in the fosfomycin
cohort and 200 patients in the control cohort (quinolones or beta-lactams).
The objectives are:
1. To asses the clinical and microbiological efficacy and safety of intravenous fosfomycin
in the treatment of complicated urinary tract infections due to Escherichia coli in real
life conditions, in comparison with a matched cohort of patients treated with quinolones
or beta-lactams.
2. To evaluate the frequency of microbiological failure and development of resistance (or
decrease in sensitivity) in Escherichia coli isolates, depending on different
pharmacokinetic and pharmacodynamic parameters, with special emphasis on fAUC0-24/MIC.
3. To evaluate the frequency of microbiological failure and development of resistance (or
decrease in sensitivity) and their association with the existence of basal mutations in
genes related to intracellular transport or regulation of these transporters.
For objective 1, a study of prospective mated cohorts (fosfomycin cohort versus quinolones or
beta-lactams cohort) will be performed, and for objectives 2 and 3 a prospective cohort study
(fosfomycin cohort) will be conducted.
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