check_circleStudy Completed

Urinary Tract Infection

Bayer Identifier:

11454

ClinicalTrials.gov Identifier:

NCT00668122

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy and safety of CIPRO XR versus CIPRO IR in patients with Complicated Urinary Tract Infections

Trial 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).

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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.
  • - 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

Trial summary

Enrollment Goal
212
Trial Dates
March 2004 - January 2006
Phase
Phase 3
Could I Receive a placebo
No
Products
Cipro XR (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
A.O.U. Federico IINapoli, 80131, Italy
Completed
A.O.U. Policlinico ConsorzialeBari, 70124, Italy
Completed
AULSS 03 Bassano Gr - VenetoBassano del Grappa, 36061, Italy
Completed
Ospedale Vittorio EmanueleCatania, 95124, Italy
Terminated
P.O. Umberto IFrosinone, 03100, Italy
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Completed
A.O. San Gerardo di MonzaMonza, 20052, Italy
Terminated
A.O. Antonio CardarelliNapoli, 80131, Italy
Completed
A.O.U. Policlinico GiacconePalermo, 90129, Italy
Completed
A.O. Ospedale San CarloPotenza, 85100, Italy
Completed
A.O. Bianchi-Melacrino-MorelliReggio Calabria, 89124, Italy
Completed
A.O. di Reggio EmiliaReggio Emilia, 42100, Italy
Terminated
AUSL Rimini - Emilia RomagnaRimini, 47900, Italy
Completed
A.O.U. Policlinico Umberto IRoma, 00155, Italy
Completed
ASL RM/C Roma - LazioRoma, 00144, Italy
Completed
Università Cattolica del Sacro CuoreRoma, 00168, Italy
Completed
Ospedale Villa ScassiGenova, 16149, Italy
Completed
ASL TO/2 - PiemonteTorino, 10154, Italy
Completed
A.O.U. Ospedali Riuniti TriesteTrieste, 34149, Italy
Terminated
A.O. Osp Circolo e Fond.MacchiVarese, 21100, Italy
Completed
A.O.U. Policlinico S.Orsola-MalpighiBologna, 40138, Italy
Terminated
Casa Cura Villa Pini d'AbruzzoChieti, 66100, Italy
Completed
A.O. SS Antonio-Biagio-ArrigoAlessandria, 15100, Italy
Completed
A.O. Gaetano RummoBenevento, 82100, Italy
Completed
Clinica Gavazzeni HumanitasBergamo, 24125, Italy
Terminated
Ospedale Civile di Busto ArsizioBusto Arsizio, 21052, Italy
Terminated
Ospedale Civile di SamposanpieroCamposampiero, 35012, Italy
Completed
A.O.U. CareggiFirenze, 50139, Italy
Terminated
A.O.U. San MartinoGenova, 16132, Italy
Completed
AUSL 4 L'Aquila - AbruzzoL'Aquila, 67100, Italy
Completed
A.O. Carlo PomaMantova, 46100, Italy
Terminated
AUSL 01 Massa-Carrara - ToscanaMassa Carrara, 54100, Italy
Completed
A.O. Papardo di MessinaMessina, 98165, Italy
Completed
A.O.U. San Luigi GonzagaOrbassano, 10043, Italy
Completed
Policlinico Universitario MontelucePerugia, 06122, Italy
Terminated
Policlinico Universitario SassariSassari, 07100, Italy
Completed
A.O. Umberto I di SiracusaSiracusa, 96100, Italy
Completed
A.O.U. Ist.Ospitalieri VeronaVerona, 37136, Italy
Completed
A.O. Sant'Anna-San SebastianoCaserta, 81100, Italy

Primary Outcome

  • Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).
    date_rangeTime Frame:
    5-9 days
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Bacteriological outcome during treatment
    date_rangeTime Frame:
    7-14 days
    enhanced_encryption
    Safety Issue:
    no
  • Bacteriological outcome at follow-up
    date_rangeTime Frame:
    28-42 days
    enhanced_encryption
    Safety Issue:
    no
  • Clinical outcome during treatment
    date_rangeTime Frame:
    7-14 days
    enhanced_encryption
    Safety Issue:
    no
  • Clinical outcome at the test-of-cure visit
    date_rangeTime Frame:
    5-9 days
    enhanced_encryption
    Safety Issue:
    no
  • Clinical outcome at follow-up
    date_rangeTime Frame:
    28-42 days
    enhanced_encryption
    Safety Issue:
    no
  • Adverse event collection
    date_rangeTime Frame:
    28-42 days
    enhanced_encryption
    Safety Issue:
    no

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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