Official Title: “Efficacy and Safety of Ciprofloxacin Extended-Release 1000 mg Once-Daily Versus Ciprofloxacin Immediate-Release 500 mg Twice-Daily Given 7-14 Days in Patients With Complicated Urinary Tract Infections: Prospective, Randomized, Double-Blind Trial.”

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

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Cipro XR (Ciprofloxacin, BAYQ3939)
  • Ciprofloxacin XR 1000 mg orally once a day
• Drug: Cipro IR (Ciprofloxacin, BAYQ3939)
  • Ciprofloxacin IR 500 mg orally twice a day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • n/a
• Experimental: Arm 2
  • n/a

Primary Measures

• The primary efficacy variable was the bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).
  • Time Frame: 5-9 days
    Safety Issue?: No

Secondary Measures

• Bacteriological outcome during treatment
  • Time Frame: 7-14 days
    Safety Issue?: No
• Bacteriological outcome at follow-up
  • Time Frame: 28-42 days
    Safety Issue?: No
• Clinical outcome during treatment
  • Time Frame: 7-14 days
    Safety Issue?: No
• Clinical outcome at the test-of-cure visit
  • Time Frame: 5-9 days
    Safety Issue?: No
• Clinical outcome at follow-up
  • Time Frame: 28-42 days
    Safety Issue?: No
• Safety
  • Time Frame: 28-42 days
    Safety Issue?: 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 (> 38oC, 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 (>38oC 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668122

Study ID Number: 11454

ClinicalTrials.gov Identifier: NCT00668122

Health Authority: Italy: The Italian Medicines Agency

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