Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated
Urinary Syndromes (FOCUS)
Does the drug Fosfomycin work better or worse than the drug levofoxacin in treating
urinary tract infections?
Basic Study Information
This is a Phase 4, multi-center, open-label, randomized pragmatic superiority clinical
comparing two strategies for initial or step-down oral therapy for complicated urinary
infections (cUTI) after 0-48 hours of parenteral antibiotic therapy. The trial will
the success and safety of a strategy of initial or step-down fosfomycin, administered
dose of 3 g once daily, vs. a strategy of initial or step-down levofloxacin administered
dose of 750 mg once daily. Investigator-directed adjustment to another adequate oral
is allowed 1) if the causative pathogen is not susceptible in vitro to quinolone initial
step-down therapy in a subject randomized to the levofloxacin strategy, OR 2) if the
develops a significant related AE (either grade 3 or at the investigator's discretion)
initial or step-down oral therapy. The duration of oral therapy (initial +
investigator-directed adjustment if indicated) in each strategy is 5-7 days of any
protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy
on creatinine clearance (CrCl). The trial will enroll approximately 536 patients that
either male or female aged 18 or older with cUTI from outpatient and inpatient settings.
study will take place over 25 months in approximately 12 to 15 US sites. The primary
objective is to compare Strategy 1 and Strategy 2 in terms of treatment success rates
of Cure (TOC).
Study Contact InformationStudy Coordinator: Nadine Rouphael
Additional Study Details
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