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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Ciprofloxacin

Criteria

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