Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections
EMERON
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.
1 other identifier
interventional
212
1 country
38
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2004
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedJune 30, 2009
June 1, 2009
April 24, 2008
June 29, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).
5-9 days
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
- mL of residual urine after voiding.
- Neurogenic bladder.
- Obstructive uropathy due to lithiasis, tumor or fibrosis.
- Acute urinary retention in men.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (38)
Unknown Facility
Monza, Milano, 20052, Italy
Unknown Facility
Camposampiero, Padova, 35012, Italy
Unknown Facility
Orbassano, Torino, 10043, Italy
Unknown Facility
Busto Arsizio, Varese, 21052, Italy
Unknown Facility
Bassano del Grappa, Vicenza, 36061, Italy
Unknown Facility
Alessandria, 15100, Italy
Unknown Facility
Bari, 70124, Italy
Unknown Facility
Benevento, 82100, Italy
Unknown Facility
Bergamo, 24125, Italy
Unknown Facility
Bologna, 40138, Italy
Unknown Facility
Caserta, 81100, Italy
Unknown Facility
Catania, 95124, Italy
Unknown Facility
Chieti, 66100, Italy
Unknown Facility
Florence, 50139, Italy
Unknown Facility
Frosinone, 03100, Italy
Unknown Facility
Genova, 16132, Italy
Unknown Facility
Genova, 16149, Italy
Unknown Facility
L’Aquila, 67100, Italy
Unknown Facility
Mantova, 46100, Italy
Unknown Facility
Massa Carrara, 54100, Italy
Unknown Facility
Messina, 98165, Italy
Unknown Facility
Milan, 20132, Italy
Unknown Facility
Napoli, 80131, Italy
Unknown Facility
Palermo, 90129, Italy
Unknown Facility
Perugia, 06122, Italy
Unknown Facility
Potenza, 85100, Italy
Unknown Facility
Reggio Calabria, 89124, Italy
Unknown Facility
Reggio Emilia, 42100, Italy
Unknown Facility
Rimini, 47900, Italy
Unknown Facility
Roma, 00144, Italy
Unknown Facility
Roma, 00155, Italy
Unknown Facility
Roma, 00168, Italy
Unknown Facility
Sassari, 07100, Italy
Unknown Facility
Syracuse, 96100, Italy
Unknown Facility
Torino, 10154, Italy
Unknown Facility
Trieste, 34149, Italy
Unknown Facility
Varese, 21100, Italy
Unknown Facility
Verona, 37136, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 24, 2008
First Posted
April 28, 2008
Study Start
March 1, 2004
Study Completion
January 1, 2006
Last Updated
June 30, 2009
Record last verified: 2009-06