To assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR) tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet 500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial urinary tract infections (cUTI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
212
Ciprofloxacin XR 1000 mg orally once a day
Ciprofloxacin IR 500 mg orally twice a day
Unnamed facility
Monza, Milano, Italy
Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).
Time frame: 5-9 days
Bacteriological outcome during treatment
Time frame: 7-14 days
Bacteriological outcome at follow-up
Time frame: 28-42 days
Clinical outcome during treatment
Time frame: 7-14 days
Clinical outcome at the test-of-cure visit
Time frame: 5-9 days
Clinical outcome at follow-up
Time frame: 28-42 days
Adverse event collection
Time frame: 28-42 days
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Unnamed facility
Camposampiero, Padova, Italy
Unnamed facility
Orbassano, Torino, Italy
Unnamed facility
Busto Arsizio, Varese, Italy
Unnamed facility
Bassano del Grappa, Vicenza, Italy
Unnamed facility
Alessandria, Italy
Unnamed facility
Bari, Italy
Unnamed facility
Benevento, Italy
Unnamed facility
Bergamo, Italy
Unnamed facility
Bologna, Italy
...and 28 more locations