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

Last updated: June 29, 2009
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Urinary Tract Infections

Bladder Disorders

Enuresis

Treatment

N/A

Clinical Study ID

NCT00668122
11454
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria: The primary diagnosis in this clinical trial was cUTI in men or non-pregnant women over 18years 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

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 andtrivalent 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 Design

Total Participants: 212
Study Start date:
March 01, 2004
Estimated Completion Date:
January 31, 2006

Connect with a study center

  • Monza, Milano 20052
    Italy

    Site Not Available

  • Camposampiero, Padova 35012
    Italy

    Site Not Available

  • Orbassano, Torino 10043
    Italy

    Site Not Available

  • Busto Arsizio, Varese 21052
    Italy

    Site Not Available

  • Bassano del Grappa, Vicenza 36061
    Italy

    Site Not Available

  • Alessandria, 15100
    Italy

    Site Not Available

  • Bari, 70124
    Italy

    Site Not Available

  • Benevento, 82100
    Italy

    Site Not Available

  • Bergamo, 24125
    Italy

    Site Not Available

  • Bologna, 40138
    Italy

    Site Not Available

  • Caserta, 81100
    Italy

    Site Not Available

  • Catania, 95124
    Italy

    Site Not Available

  • Chieti, 66100
    Italy

    Site Not Available

  • Firenze, 50139
    Italy

    Site Not Available

  • Frosinone, 03100
    Italy

    Site Not Available

  • Genova, 16132
    Italy

    Site Not Available

  • L'Aquila, 67100
    Italy

    Site Not Available

  • Mantova, 46100
    Italy

    Site Not Available

  • Massa Carrara, 54100
    Italy

    Site Not Available

  • Messina, 98165
    Italy

    Site Not Available

  • Milano, 20132
    Italy

    Site Not Available

  • Napoli, 80131
    Italy

    Site Not Available

  • Palermo, 90129
    Italy

    Site Not Available

  • Perugia, 06122
    Italy

    Site Not Available

  • Potenza, 85100
    Italy

    Site Not Available

  • Reggio Calabria, 89124
    Italy

    Site Not Available

  • Reggio Emilia, 42100
    Italy

    Site Not Available

  • Rimini, 47900
    Italy

    Site Not Available

  • Roma, 00155
    Italy

    Site Not Available

  • Sassari, 07100
    Italy

    Site Not Available

  • Siracusa, 96100
    Italy

    Site Not Available

  • Torino, 10154
    Italy

    Site Not Available

  • Trieste, 34149
    Italy

    Site Not Available

  • Varese, 21100
    Italy

    Site Not Available

  • Verona, 37136
    Italy

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.