check_circleStudy Completed
Bacterial Infections
Bayer Identifier:
100588
ClinicalTrials.gov Identifier:
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
MaleAge
18 YearsTrial summary
Enrollment Goal
497Trial Dates
April 2004 - October 2004Phase
Phase 3Could I Receive a placebo
NoProducts
Cipro XR (Ciprofloxacin, BAYQ3939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Centre de Recherche Clinique en Urologie | Quebec, G1S 2L6, Canada |
Completed | IRCCS Fondazione San Raffaele | Milano, 20132, Italy |
Completed | Hospital General de Occidente, S.S. | Zapopan, 45170, Mexico |
Completed | Hospital Ramón y Cajal | Madrid, 28034, Spain |
Terminated | A.O.U. Federico II | Napoli, 80131, Italy |
Completed | Centro Medico de Especilidades Medicas del Norte No 25 IMSS | Monterrey, 64320, Mexico |
Completed | Office of Dr. Roger Fincher, MD | Spokane, 99202, United States |
Completed | Ciutat Sanitària i Universitaria de la Vall d'Hebrón | Barcelona, 08035, Spain |
Completed | A.O.U. Policlinico Umberto I | Roma, 00155, Italy |
Completed | Clinique Medicale du Fjord | Chicoutimi, G7H 1H2, Canada |
Completed | Hospital do Meixoeiro | Vigo, 36214, Spain |
Completed | A.O. di Padova | Padova, 35128, Italy |
Completed | The Urology Group | Cincinnati, 45212-2787, United States |
Completed | Complejo Hospitalario Ntra. Sra. de Valme | Sevilla, 41014, Spain |
Completed | Hospital General "Dr. Juan Graham Casasus" | Villahermosa, 86158, Mexico |
Completed | San Diego Uro-Research | San Diego, 92101, United States |
Completed | Santa Casa de Misericordia de Porto Alegre | Porto Alegre, 90470 340, Brazil |
Completed | Hospital Universitario La Fe | Valencia, 46009, Spain |
Completed | Urology Specialists, PC | Waterbury, 06708, United States |
Completed | Inst. de Assistência Médica ao Sérvidor Público Estadual | São Paulo, 04039-004, Brazil |
Terminated | Kingston General Hospital | Kingston, K7L 2V7, Canada |
Completed | Hospital Universitario Pedro Ernesto | Rio de Janeiro, Brazil |
Completed | Cente Hospitalier Universitaire de Sherbrooke-Fleurimont | Fleurimont, J1H 5N4, Canada |
Terminated | Centro Médico Nacional Siglo XXI IMSS | México D.F., 06720, Mexico |
Completed | Florida Foundation for Healthcare Research | Ocala, 34474, United States |
Completed | Hospital Universitário São José - FCMMG | Belo Horizonte, Brazil |
Completed | Hospital Juárez de México SS | México, D.F., 07760, Mexico |
Terminated | Hospital Alianca (Centro Médico) | Salvador, 41920 000, Brazil |
Completed | CAN-MED Clinical Research, Inc | Victoria, V8R 6T9, Canada |
Completed | A.O. Ospedali Riuniti Bergamo | Bergamo, 24128, Italy |
Completed | Hospital Maria José | México, D. F., 06700, Mexico |
Completed | Polyclinique Medicale Concorde Urologie | Laval, H7G 2E6, Canada |
Completed | Alabama Research Center, LLC | Birmingham, 35209, United States |
Completed | East York Diagnostic Ultrasound | Toronto, M4H 1C3, Canada |
Terminated | Robert Wood Johnson Medical School | New Brunswick, 08901, United States |
Completed | Prostate Cancer Institute | Calgary, T2V 4R6, Canada |
Completed | Georgia Urology, PA | Atlanta, 30342, United States |
Completed | St.Joseph's Health Care-London | London, N6A 4V2, Canada |
Completed | Greenville Urology- Holly Tree | Simpsonville, 29681, United States |
Completed | Columbus Urology Research, LLC | Columbus, 43214-1419, United States |
Completed | Urology Consultants, PA | San Antonio, 78229, United States |
Completed | Sunnybrook Health Sciences Centre | Toronto, M4N 3M5, Canada |
Completed | Edmonton Prostate & Urological Centre | Edmonton, T6G 2C8, Canada |
Completed | Office of Dr. Lewis S. Kriteman, MD | Roswell, 30076, United States |
Completed | Hamilton District Urology Association | Hamilton, L8N 1T8, Canada |
Completed | Devine -Tidewater Urology | Norfolk, 23510, United States |
Completed | Milford Urology | Hopedale, 01747, United States |
Completed | Thomas Jefferson University | Philadelphia, 19107, United States |
Completed | Northwestern University Feinberg School of Medicine | Chicago, 60611, United States |
Completed | Sherman Oaks Urological Medical Group | Sherman Oaks, 91403, United States |
Completed | University of California, San Francisco | San Francisco, 94117, United States |
Primary Outcome
- Bacteriological Response (bacteriuria vs. no bacteriuria)date_rangeTime Frame:10-14 days after last dose of study medenhanced_encryptionnoSafety Issue:
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_encryptionnoSafety Issue:
- Incidence of post-procedure GU tract infections other than bacteriuriadate_rangeTime Frame:any time after the TRNBPenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2