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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00668122
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : June 30, 2009
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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).

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Drug: Cipro XR (Ciprofloxacin, BAYQ3939) Drug: Cipro IR (Ciprofloxacin, BAYQ3939) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2004
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1 Drug: Cipro XR (Ciprofloxacin, BAYQ3939)
Ciprofloxacin XR 1000 mg orally once a day

Experimental: Arm 2 Drug: Cipro IR (Ciprofloxacin, BAYQ3939)
Ciprofloxacin IR 500 mg orally twice a day

Primary Outcome Measures :
  1. Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit). [ Time Frame: 5-9 days ]

Secondary Outcome Measures :
  1. Bacteriological outcome during treatment [ Time Frame: 7-14 days ]
  2. Bacteriological outcome at follow-up [ Time Frame: 28-42 days ]
  3. Clinical outcome during treatment [ Time Frame: 7-14 days ]
  4. Clinical outcome at the test-of-cure visit [ Time Frame: 5-9 days ]
  5. Clinical outcome at follow-up [ Time Frame: 28-42 days ]
  6. Adverse event collection [ Time Frame: 28-42 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00668122

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Monza, Milano, Italy, 20052
Camposampiero, Padova, Italy, 35012
Orbassano, Torino, Italy, 10043
Busto Arsizio, Varese, Italy, 21052
Bassano del Grappa, Vicenza, Italy, 36061
Alessandria, Italy, 15100
Bari, Italy, 70124
Benevento, Italy, 82100
Bergamo, Italy, 24125
Bologna, Italy, 40138
Caserta, Italy, 81100
Catania, Italy, 95124
Chieti, Italy, 66100
Firenze, Italy, 50139
Frosinone, Italy, 03100
Genova, Italy, 16132
Genova, Italy, 16149
L'Aquila, Italy, 67100
Mantova, Italy, 46100
Massa Carrara, Italy, 54100
Messina, Italy, 98165
Milano, Italy, 20132
Napoli, Italy, 80131
Palermo, Italy, 90129
Perugia, Italy, 06122
Potenza, Italy, 85100
Reggio Calabria, Italy, 89124
Reggio Emilia, Italy, 42100
Rimini, Italy, 47900
Roma, Italy, 00144
Roma, Italy, 00155
Roma, Italy, 00168
Sassari, Italy, 07100
Siracusa, Italy, 96100
Torino, Italy, 10154
Trieste, Italy, 34149
Varese, Italy, 21100
Verona, Italy, 37136
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT00668122    
Other Study ID Numbers: 11454
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009
Additional relevant MeSH terms:
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Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors