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

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Drug: Cipro XR (Ciprofloxacin, BAYQ3939)
* Drug: Cipro IR (Ciprofloxacin, BAYQ3939)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Cipro XR (Ciprofloxacin, BAYQ3939)<br>* Ciprofloxacin XR 1000 mg orally once a day<br>|
| Experimental: Arm 2<br> | Drug: Cipro IR (Ciprofloxacin, BAYQ3939)<br>* Ciprofloxacin IR 500 mg orally twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit). |  | 5-9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriological outcome during treatment |  | 7-14 days | 
| Bacteriological outcome at follow-up |  | 28-42 days | 
| Clinical outcome during treatment |  | 7-14 days | 
| Clinical outcome at the test-of-cure visit |  | 5-9 days | 
| Clinical outcome at follow-up |  | 28-42 days | 
| Adverse event collection |  | 28-42 days |