Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections
Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections
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).
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