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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.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00668122
First received: April 24, 2008
Last updated: June 29, 2009
Last verified: June 2009
History of Changes
  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).


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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bacteriological outcome during treatment [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Bacteriological outcome at follow-up [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]
  • Clinical outcome during treatment [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Clinical outcome at the test-of-cure visit [ Time Frame: 5-9 days ] [ Designated as safety issue: No ]
  • Clinical outcome at follow-up [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]
  • Adverse event collection [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668122

Locations
Italy
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, 16149
Genova, Italy, 16132
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, 00155
Roma, Italy, 00144
Roma, Italy, 00168
Sassari, Italy, 07100
Siracusa, Italy, 96100
Torino, Italy, 10154
Trieste, Italy, 34149
Varese, Italy, 21100
Verona, Italy, 37136
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00668122     History of Changes
Other Study ID Numbers: 11454
Study First Received: April 24, 2008
Last Updated: June 29, 2009
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013