Status:
COMPLETED
Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections
Lead Sponsor:
Bayer
Conditions:
Urinary Tract Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-da...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00668122
Start Date
March 1 2004
End Date
January 1 2006
Last Update
June 30 2009
Active Locations (38)
Enter a location and click search to find clinical trials sorted by distance.
1
Monza, Milano, Italy, 20052
2
Camposampiero, Padova, Italy, 35012
3
Orbassano, Torino, Italy, 10043
4
Busto Arsizio, Varese, Italy, 21052