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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: April 24, 2008
Last updated: June 29, 2009
Last verified: June 2009
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 Intervention Phase
Urinary Tract Infection
Drug: Cipro XR (Ciprofloxacin, BAYQ3939)
Drug: Cipro IR (Ciprofloxacin, BAYQ3939)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Further study details as provided by Bayer:

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

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

Enrollment: 212
Study Start Date: March 2004
Study Completion Date: January 2006
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00668122

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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT00668122     History of Changes
Other Study ID Numbers: 11454
Study First Received: April 24, 2008
Last Updated: June 29, 2009

Additional relevant MeSH terms:
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 processed this record on March 29, 2017