Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections
Phase 3
Completed
- Conditions
- Urinary Tract Infection
- Interventions
- Registration Number
- NCT00668122
- Lead Sponsor
- Bayer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 212
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.
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Cipro IR (Ciprofloxacin, BAYQ3939) - Arm 1 Cipro XR (Ciprofloxacin, BAYQ3939) -
- Primary Outcome Measures
Name Time Method Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit). 5-9 days
- Secondary Outcome Measures
Name Time Method 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