Trial Condition(s):
Bacterial Infections
BAYQ3939, 1000 mg tablet in transrectal needle biopsies of the prostate (TRNBP) - infection prophylaxis
Bayer Identifier:
100588
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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).
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Centre de Recherche Clinique en Urologie Quebec, Canada, G1S 2L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General de Occidente, S.S. Zapopan, Mexico, 45170 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Ramón y Cajal Madrid, Spain, 28034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Federico II Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Medico de Especilidades Medicas del Norte No 25 IMSS Monterrey, Mexico, 64320 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Roger Fincher, MD Spokane, United States, 99202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebrón Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Umberto I Roma, Italy, 00155 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Medicale du Fjord Chicoutimi, Canada, G7H 1H2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital do Meixoeiro Vigo, Spain, 36214 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Padova Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Urology Group Cincinnati, United States, 45212-2787 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Complejo Hospitalario Ntra. Sra. de Valme Sevilla, Spain, 41014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General "Dr. Juan Graham Casasus" Villahermosa, Mexico, 86158 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations San Diego Uro-Research San Diego, United States, 92101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Santa Casa de Misericordia de Porto Alegre Porto Alegre, Brazil, 90470 340 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario La Fe Valencia, Spain, 46009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urology Specialists, PC Waterbury, United States, 06708 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inst. de Assistência Médica ao Sérvidor Público Estadual São Paulo, Brazil, 04039-004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kingston General Hospital Kingston, Canada, K7L 2V7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Pedro Ernesto Rio de Janeiro, Brazil | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cente Hospitalier Universitaire de Sherbrooke-Fleurimont Fleurimont, Canada, J1H 5N4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Médico Nacional Siglo XXI IMSS México D.F., Mexico, 06720 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Florida Foundation for Healthcare Research Ocala, United States, 34474 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitário São José - FCMMG Belo Horizonte, Brazil | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Juárez de México SS México, D.F., Mexico, 07760 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Alianca (Centro Médico) Salvador, Brazil, 41920 000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CAN-MED Clinical Research, Inc Victoria, Canada, V8R 6T9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Ospedali Riuniti Bergamo Bergamo, Italy, 24128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Maria José México, D. F., Mexico, 06700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Polyclinique Medicale Concorde Urologie Laval, Canada, H7G 2E6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Alabama Research Center, LLC Birmingham, United States, 35209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations East York Diagnostic Ultrasound Toronto, Canada, M4H 1C3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Robert Wood Johnson Medical School New Brunswick, United States, 08901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prostate Cancer Institute Calgary, Canada, T2V 4R6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Georgia Urology, PA Atlanta, United States, 30342 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St.Joseph's Health Care-London London, Canada, N6A 4V2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Greenville Urology- Holly Tree Simpsonville, United States, 29681 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbus Urology Research, LLC Columbus, United States, 43214-1419 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urology Consultants, PA San Antonio, United States, 78229 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunnybrook Health Sciences Centre Toronto, Canada, M4N 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edmonton Prostate & Urological Centre Edmonton, Canada, T6G 2C8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Lewis S. Kriteman, MD Roswell, United States, 30076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hamilton District Urology Association Hamilton, Canada, L8N 1T8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Devine -Tidewater Urology Norfolk, United States, 23510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Milford Urology Hopedale, United States, 01747 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thomas Jefferson University Philadelphia, United States, 19107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northwestern University Feinberg School of Medicine Chicago, United States, 60611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sherman Oaks Urological Medical Group Sherman Oaks, United States, 91403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California, San Francisco San Francisco, United States, 94117 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Bacteriological Response (bacteriuria vs. no bacteriuria)Timeframe: 10-14 days after last dose of study med
Secondary Outcome
- Clinical Response (patients without clinical symptoms or signs of bacteriuria vs. patients with clinical symptoms or signs of bacteriuria)Timeframe: 10-14 days after last dose of study med.
- Incidence of post-procedure GU tract infections other than bacteriuriaTimeframe: any time after the TRNBP
Additional Information
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