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:

NCT00670215

EudraCT Number:

Not Available

Study Completed

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
497
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Cipro XR (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Centre de Recherche Clinique en Urologie

Quebec, Canada, G1S 2L6

Status
Completed
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

Hospital General de Occidente, S.S.

Zapopan, Mexico, 45170

Status
Completed
 
Locations

Hospital Ramón y Cajal

Madrid, Spain, 28034

Status
Completed
 
Locations

A.O.U. Federico II

Napoli, Italy, 80131

Status
Terminated
 
Locations

Centro Medico de Especilidades Medicas del Norte No 25 IMSS

Monterrey, Mexico, 64320

Status
Completed
 
Locations

Office of Dr. Roger Fincher, MD

Spokane, United States, 99202

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebrón

Barcelona, Spain, 08035

Status
Completed
 
Locations

A.O.U. Policlinico Umberto I

Roma, Italy, 00155

Status
Completed
 
Locations

Clinique Medicale du Fjord

Chicoutimi, Canada, G7H 1H2

Status
Completed
 
Locations

Hospital do Meixoeiro

Vigo, Spain, 36214

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

The Urology Group

Cincinnati, United States, 45212-2787

Status
Completed
 
Locations

Complejo Hospitalario Ntra. Sra. de Valme

Sevilla, Spain, 41014

Status
Completed
 
Locations

Hospital General "Dr. Juan Graham Casasus"

Villahermosa, Mexico, 86158

Status
Completed
 
Locations

San Diego Uro-Research

San Diego, United States, 92101

Status
Completed
 
Locations

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90470 340

Status
Completed
 
Locations

Hospital Universitario La Fe

Valencia, Spain, 46009

Status
Completed
 
Locations

Urology Specialists, PC

Waterbury, United States, 06708

Status
Completed
 
Locations

Inst. de Assistência Médica ao Sérvidor Público Estadual

São Paulo, Brazil, 04039-004

Status
Completed
 
Locations

Kingston General Hospital

Kingston, Canada, K7L 2V7

Status
Terminated
 
Locations

Hospital Universitario Pedro Ernesto

Rio de Janeiro, Brazil

Status
Completed
 
Locations

Cente Hospitalier Universitaire de Sherbrooke-Fleurimont

Fleurimont, Canada, J1H 5N4

Status
Completed
 
Locations

Centro Médico Nacional Siglo XXI IMSS

México D.F., Mexico, 06720

Status
Terminated
 
Locations

Florida Foundation for Healthcare Research

Ocala, United States, 34474

Status
Completed
 
Locations

Hospital Universitário São José - FCMMG

Belo Horizonte, Brazil

Status
Completed
 
Locations

Hospital Juárez de México SS

México, D.F., Mexico, 07760

Status
Completed
 
Locations

Hospital Alianca (Centro Médico)

Salvador, Brazil, 41920 000

Status
Terminated
 
Locations

CAN-MED Clinical Research, Inc

Victoria, Canada, V8R 6T9

Status
Completed
 
Locations

A.O. Ospedali Riuniti Bergamo

Bergamo, Italy, 24128

Status
Completed
 
Locations

Hospital Maria José

México, D. F., Mexico, 06700

Status
Completed
 
Locations

Polyclinique Medicale Concorde Urologie

Laval, Canada, H7G 2E6

Status
Completed
 
Locations

Alabama Research Center, LLC

Birmingham, United States, 35209

Status
Completed
 
Locations

East York Diagnostic Ultrasound

Toronto, Canada, M4H 1C3

Status
Completed
 
Locations

Robert Wood Johnson Medical School

New Brunswick, United States, 08901

Status
Terminated
 
Locations

Prostate Cancer Institute

Calgary, Canada, T2V 4R6

Status
Completed
 
Locations

Georgia Urology, PA

Atlanta, United States, 30342

Status
Completed
 
Locations

St.Joseph's Health Care-London

London, Canada, N6A 4V2

Status
Completed
 
Locations

Greenville Urology- Holly Tree

Simpsonville, United States, 29681

Status
Completed
 
Locations

Columbus Urology Research, LLC

Columbus, United States, 43214-1419

Status
Completed
 
Locations

Urology Consultants, PA

San Antonio, United States, 78229

Status
Completed
 
Locations

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

Edmonton Prostate & Urological Centre

Edmonton, Canada, T6G 2C8

Status
Completed
 
Locations

Office of Dr. Lewis S. Kriteman, MD

Roswell, United States, 30076

Status
Completed
 
Locations

Hamilton District Urology Association

Hamilton, Canada, L8N 1T8

Status
Completed
 
Locations

Devine -Tidewater Urology

Norfolk, United States, 23510

Status
Completed
 
Locations

Milford Urology

Hopedale, United States, 01747

Status
Completed
 
Locations

Thomas Jefferson University

Philadelphia, United States, 19107

Status
Completed
 
Locations

Northwestern University Feinberg School of Medicine

Chicago, United States, 60611

Status
Completed
 
Locations

Sherman Oaks Urological Medical Group

Sherman Oaks, United States, 91403

Status
Completed
 
Locations

University of California, San Francisco

San Francisco, United States, 94117

Status
Completed
 

Trial Design