Trial Condition(s):
Urinary Tract Infection
Efficacy and safety of CIPRO XR versus CIPRO IR in patients with Complicated Urinary Tract Infections (EMERON)
Bayer Identifier:
11454
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bari, Italy, 70124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bassano del Grappa, Italy, 36061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Catania, Italy, 95124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frosinone, Italy, 03100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monza, Italy, 20052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palermo, Italy, 90129 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Potenza, Italy, 85100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reggio Calabria, Italy, 89124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reggio Emilia, Italy, 42100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rimini, Italy, 47900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00155 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10154 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trieste, Italy, 34149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varese, Italy, 21100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chieti, Italy, 66100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alessandria, Italy, 15100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Benevento, Italy, 82100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bergamo, Italy, 24125 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Busto Arsizio, Italy, 21052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Camposampiero, Italy, 35012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Firenze, Italy, 50139 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site L'Aquila, Italy, 67100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mantova, Italy, 46100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Massa Carrara, Italy, 54100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Messina, Italy, 98165 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orbassano, Italy, 10043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perugia, Italy, 06122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sassari, Italy, 07100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Siracusa, Italy, 96100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Verona, Italy, 37136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Caserta, Italy, 81100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).Timeframe: 5-9 days
Secondary Outcome
- Bacteriological outcome during treatmentTimeframe: 7-14 days
- Bacteriological outcome at follow-upTimeframe: 28-42 days
- Clinical outcome during treatmentTimeframe: 7-14 days
- Clinical outcome at the test-of-cure visitTimeframe: 5-9 days
- Clinical outcome at follow-upTimeframe: 28-42 days
- Adverse event collectionTimeframe: 28-42 days
Additional Information
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