Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS)
Status:
Terminated
Trial end date:
2019-10-24
Target enrollment:
Participant gender:
Summary
This is a Phase 4, multi-center, open-label, randomized pragmatic superiority clinical trial
comparing two strategies for initial or step-down oral therapy for complicated urinary tract
infections (cUTI) after 0-48 hours of parenteral antibiotic therapy. The trial will evaluate
the success and safety of a strategy of initial or step-down fosfomycin, administered at a
dose of 3 g once daily, vs. a strategy of initial or step-down levofloxacin administered at a
dose of 750 mg once daily. Investigator-directed adjustment to another adequate oral therapy
is allowed 1) if the causative pathogen is not susceptible in vitro to quinolone initial or
step-down therapy in a subject randomized to the levofloxacin strategy, OR 2) if the subject
develops an intolerance or allergy to the initial step-down oral therapy and at the
investigator's discretion, OR 3) the subject has an underlying condition posing increasing
risk for adverse events from quinolone therapy. The duration of oral therapy (initial +
investigator-directed adjustment if indicated) in each strategy is 5-7 days of any per
protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends
on creatinine clearance (CrCl). The trial will enroll approximately 634 patients that are
either male or female aged 18 or older with cUTI from outpatient and inpatient settings. The
study will take place over 25 months in up to 15 US sites. The primary objective is to
compare Strategy 1 and Strategy 2 in terms of treatment success rates at Test of Cure (TOC).
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)