Urinary Tract Infection
Conditions
Brief summary
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).
Interventions
Ciprofloxacin XR 1000 mg orally once a day
DRUGCipro IR (Ciprofloxacin, BAYQ3939)
Ciprofloxacin IR 500 mg orally twice a day
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The primary diagnosis in this clinical trial was cUTI in men or non-pregnant women over 18 years of age. Other main inclusion criteria: * One or more clinical symptoms and signs of a lower UTI: fever (\> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation. * One or more of the following underlying conditions suggestive of cUTI: * Indwelling urinary catheter. * 100 mL of residual urine after voiding. * Neurogenic bladder. * Obstructive uropathy due to lithiasis, tumor or fibrosis. * Acute urinary retention in men.
Exclusion criteria
Diagnosis of pyelonephritis supported by clinical signs/symptoms of fever (\>38°C orally), chills and flank pain (all 3 signs/symptoms must be present). * Have a history of allergy to quinolones * Are unable to take oral medication * Have an intractable infection requiring \> 14 days of therapy * Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium * Have prostatitis or epididymitis * Have had a renal transplant * Have ileal loop or vesica- urethral reflux * Have significant liver or kidney impairment * Have a history of tendinopathy associated with fluoroquinolones * Are pregnant, nursing * Have a history of convulsions or CNS disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit). | 5-9 days |
Secondary
| Measure | Time frame |
|---|---|
| Bacteriological outcome at follow-up | 28-42 days |
| Clinical outcome during treatment | 7-14 days |
| Bacteriological outcome during treatment | 7-14 days |
| Clinical outcome at follow-up | 28-42 days |
| Adverse event collection | 28-42 days |
| Clinical outcome at the test-of-cure visit | 5-9 days |
Countries
Italy
Outcome results
None listed