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.

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).

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Drug: Cipro XR (Ciprofloxacin, BAYQ3939); Drug: Cipro IR (Ciprofloxacin, BAYQ3939)

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • 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, 00168
  • Roma, Italy, 00144
  • Roma, Italy, 00155
  • Sassari, Italy, 07100
  • Siracusa, Italy, 96100
  • Torino, Italy, 10154
  • Trieste, Italy, 34149
  • Varese, Italy, 21100
  • Verona, Italy, 37136
  • Milano
    • Monza, Milano, Italy, 20052
  • Padova
    • Camposampiero, Padova, Italy, 35012
  • Torino
    • Orbassano, Torino, Italy, 10043
  • Varese
    • Busto Arsizio, Varese, Italy, 21052
  • Vicenza
    • Bassano del Grappa, Vicenza, Italy, 36061

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).	5-9 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Adverse event collection	28-42 days

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: April 24, 2008
• First Submitted That Met QC Criteria: April 27, 2008
• First Posted (Estimate): April 28, 2008

Study Record Updates

• Last Update Posted (Estimate): June 30, 2009
• Last Update Submitted That Met QC Criteria: June 29, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 11454