check_circleStudy Completed

Bacterial Infections

Bayer Identifier:

100588

ClinicalTrials.gov Identifier:

NCT00670215

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAYQ3939, 1000 mg tablet in transrectal needle biopsies of the prostate (TRNBP) - infection prophylaxis

Trial purpose

The primary purpose of this clinical trial is to compare in a double-blind randomized trial, the efficacy and safety of ciprofloxacin MR 1000 mg tablets given as a single-dose or as a multiple-dose regimen for the prevention of infectious complications in patients undergoing transrectal needle biopsies of the prostate (TRNBP).

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Transrectal needle biopsy of the prostate required.
    - A clean-catch midstream-urine (MSU) culture negative (<104 CFU/mL) for possible pathogens at the Pre-Therapy Visit prior to the TRNBP.
    - Gastrointestinal absorption is adequate as evidenced by passage of gas or feces per rectum and patient can tolerate oral food, fluids, and medication without vomiting or diarrhea.
  • - History of hypersensitivity to ciprofloxacin or other quinolone antibiotics
    - Valvular heart disease that requires antibiotic prophylaxis to prevent bacterial endocarditis
    - Concomitant use of theophylline, probenecid, or warfarin at any time during the entire study
    - Renal insufficiency
    - Known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold
    - Absolute neutrophil count (ANC) <1000/mm3
    - Human immunodeficiency virus (HIV) infection with a CD4 count <200 cells/micL. HIV testing is NOT required
    - Antibiotic administration within one week of the TRNBP
    - Severe hepatic insufficiency (Child-Pugh C)

Trial summary

Enrollment Goal
497
Trial Dates
April 2004 - October 2004
Phase
Phase 3
Could I Receive a placebo
No
Products
Cipro XR (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Centre de Recherche Clinique en UrologieQuebec, G1S 2L6, Canada
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Completed
Hospital General de Occidente, S.S.Zapopan, 45170, Mexico
Completed
Hospital Ramón y CajalMadrid, 28034, Spain
Terminated
A.O.U. Federico IINapoli, 80131, Italy
Completed
Centro Medico de Especilidades Medicas del Norte No 25 IMSSMonterrey, 64320, Mexico
Completed
Office of Dr. Roger Fincher, MDSpokane, 99202, United States
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebrónBarcelona, 08035, Spain
Completed
A.O.U. Policlinico Umberto IRoma, 00155, Italy
Completed
Clinique Medicale du FjordChicoutimi, G7H 1H2, Canada
Completed
Hospital do MeixoeiroVigo, 36214, Spain
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
The Urology GroupCincinnati, 45212-2787, United States
Completed
Complejo Hospitalario Ntra. Sra. de ValmeSevilla, 41014, Spain
Completed
Hospital General "Dr. Juan Graham Casasus"Villahermosa, 86158, Mexico
Completed
San Diego Uro-ResearchSan Diego, 92101, United States
Completed
Santa Casa de Misericordia de Porto AlegrePorto Alegre, 90470 340, Brazil
Completed
Hospital Universitario La FeValencia, 46009, Spain
Completed
Urology Specialists, PCWaterbury, 06708, United States
Completed
Inst. de Assistência Médica ao Sérvidor Público EstadualSão Paulo, 04039-004, Brazil
Terminated
Kingston General HospitalKingston, K7L 2V7, Canada
Completed
Hospital Universitario Pedro ErnestoRio de Janeiro, Brazil
Completed
Cente Hospitalier Universitaire de Sherbrooke-FleurimontFleurimont, J1H 5N4, Canada
Terminated
Centro Médico Nacional Siglo XXI IMSSMéxico D.F., 06720, Mexico
Completed
Florida Foundation for Healthcare ResearchOcala, 34474, United States
Completed
Hospital Universitário São José - FCMMGBelo Horizonte, Brazil
Completed
Hospital Juárez de México SSMéxico, D.F., 07760, Mexico
Terminated
Hospital Alianca (Centro Médico)Salvador, 41920 000, Brazil
Completed
CAN-MED Clinical Research, IncVictoria, V8R 6T9, Canada
Completed
A.O. Ospedali Riuniti BergamoBergamo, 24128, Italy
Completed
Hospital Maria JoséMéxico, D. F., 06700, Mexico
Completed
Polyclinique Medicale Concorde UrologieLaval, H7G 2E6, Canada
Completed
Alabama Research Center, LLCBirmingham, 35209, United States
Completed
East York Diagnostic UltrasoundToronto, M4H 1C3, Canada
Terminated
Robert Wood Johnson Medical SchoolNew Brunswick, 08901, United States
Completed
Prostate Cancer InstituteCalgary, T2V 4R6, Canada
Completed
Georgia Urology, PAAtlanta, 30342, United States
Completed
St.Joseph's Health Care-LondonLondon, N6A 4V2, Canada
Completed
Greenville Urology- Holly TreeSimpsonville, 29681, United States
Completed
Columbus Urology Research, LLCColumbus, 43214-1419, United States
Completed
Urology Consultants, PASan Antonio, 78229, United States
Completed
Sunnybrook Health Sciences CentreToronto, M4N 3M5, Canada
Completed
Edmonton Prostate & Urological CentreEdmonton, T6G 2C8, Canada
Completed
Office of Dr. Lewis S. Kriteman, MDRoswell, 30076, United States
Completed
Hamilton District Urology AssociationHamilton, L8N 1T8, Canada
Completed
Devine -Tidewater UrologyNorfolk, 23510, United States
Completed
Milford UrologyHopedale, 01747, United States
Completed
Thomas Jefferson UniversityPhiladelphia, 19107, United States
Completed
Northwestern University Feinberg School of MedicineChicago, 60611, United States
Completed
Sherman Oaks Urological Medical GroupSherman Oaks, 91403, United States
Completed
University of California, San FranciscoSan Francisco, 94117, United States

Primary Outcome

  • Bacteriological Response (bacteriuria vs. no bacteriuria)
    date_rangeTime Frame:
    10-14 days after last dose of study med
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Clinical Response (patients without clinical symptoms or signs of bacteriuria vs. patients with clinical symptoms or signs of bacteriuria)
    date_rangeTime Frame:
    10-14 days after last dose of study med.
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of post-procedure GU tract infections other than bacteriuria
    date_rangeTime Frame:
    any time after the TRNBP
    enhanced_encryption
    Safety Issue:
    no

Trial design

Prospective, randomized, double-blind, comparison of ciprofloxacin extended-release 1000 mg tablets given as two different prophylactic dosing regimens (Regimen I - Single-dose ciprofloxacin MR 1000 mg or Regimen II - Multiple-dose ciprofloxacin MR 1000 mg once daily for 3 days) for the prevention of post-operative infectious complications in patients undergoing transrectal needle biopsy of the prostate
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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