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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00668122
Collaborator
(none)
212
Enrollment
38
Locations
2
Arms
22
Duration (Months)
5.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Cipro XR (Ciprofloxacin, BAYQ3939)
  • Drug: Cipro IR (Ciprofloxacin, BAYQ3939)
 Phase 3

Study Design

Study Type:
Interventional
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 :
Mar 1, 2004
Actual Study Completion Date :
Jan 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit). [5-9 days]

Secondary Outcome Measures

  1. Bacteriological outcome during treatment [7-14 days]

  2. Bacteriological outcome at follow-up [28-42 days]

  3. Clinical outcome during treatment [7-14 days]

  4. Clinical outcome at the test-of-cure visit [5-9 days]

  5. Clinical outcome at follow-up [28-42 days]

  6. Adverse event collection [28-42 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Locations

Site City State Country Postal Code
1 Monza Milano Italy 20052
2 Camposampiero Padova Italy 35012
3 Orbassano Torino Italy 10043
4 Busto Arsizio Varese Italy 21052
5 Bassano del Grappa Vicenza Italy 36061
6 Alessandria Italy 15100
7 Bari Italy 70124
8 Benevento Italy 82100
9 Bergamo Italy 24125
10 Bologna Italy 40138
11 Caserta Italy 81100
12 Catania Italy 95124
13 Chieti Italy 66100
14 Firenze Italy 50139
15 Frosinone Italy 03100
16 Genova Italy 16132
17 Genova Italy 16149
18 L'Aquila Italy 67100
19 Mantova Italy 46100
20 Massa Carrara Italy 54100
21 Messina Italy 98165
22 Milano Italy 20132
23 Napoli Italy 80131
24 Palermo Italy 90129
25 Perugia Italy 06122
26 Potenza Italy 85100
27 Reggio Calabria Italy 89124
28 Reggio Emilia Italy 42100
29 Rimini Italy 47900
30 Roma Italy 00144
31 Roma Italy 00155
32 Roma Italy 00168
33 Sassari Italy 07100
34 Siracusa Italy 96100
35 Torino Italy 10154
36 Trieste Italy 34149
37 Varese Italy 21100
38 Verona Italy 37136

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00668122
Other Study ID Numbers:
  • 11454
First Posted:
Apr 28, 2008
Last Update Posted:
Jun 30, 2009
Last Verified:
Jun 1, 2009
Additional relevant MeSH terms:
Infections
Communicable Diseases
Urinary Tract Infections
Ciprofloxacin

Study Results

No Results Posted as of Jun 30, 2009