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:
- Males.
- 18-years of age or older.
- 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/μL. HIV
testing is NOT required
- Antibiotic administration within one week of the TRNBP
- Severe hepatic insufficiency (Child-Pugh C)
Rio de Janeiro, Brazil
São Paulo 04039-004, Brazil
Quebec G1S 2L6, Canada
Milano 20132, Italy
Roma 00155, Italy
Padova 35128, Italy
Bergamo 24128, Italy
Monterrey 64320, Mexico
México, D.F. 07760, Mexico
México, D. F. 06700, Mexico
Barcelona 08035, Spain
Madrid 28034, Spain
Sevilla 41014, Spain
Valencia 46009, Spain
Birmingham, Alabama 35209, United States
Calgary, Alberta T2V 4R6, Canada
Edmonton, Alberta T6G 2C8, Canada
Victoria, British Columbia V8R 6T9, Canada
San Diego, California 92101, United States
Sherman Oaks, California 91403, United States
San Francisco, California 94117, United States
Waterbury, Connecticut 06708, United States
Ocala, Florida 34474, United States
Atlanta, Georgia 30342, United States
Roswell, Georgia 30076, United States
Chicago, Illinois 60611, United States
Zapopan, Jalisco 45170, Mexico
Hopedale, Massachusetts 01747, United States
Belo Horizonte, Minas Gerais, Brazil
Cincinnati, Ohio 45212-2787, United States
Columbus, Ohio 43214-1419, United States
Toronto, Ontario M4H 1C3, Canada
Toronto, Ontario M4N 3M5, Canada
Hamilton, Ontario L8N 1T8, Canada
London, Ontario N6A 4V2, Canada
Philadelphia, Pennsylvania 19107, United States
Vigo, Pontevedra 36214, Spain
Sherbrooke, Quebec J1H 5N4, Canada
Chicoutimi, Quebec G7H 1H2, Canada
Laval, Quebec H7G 2E6, Canada
Porto Alegre, RS 90470 340, Brazil
Simpsonville, South Carolina 29681, United States
Villahermosa, Tabasco 86158, Mexico
San Antonio, Texas 78229, United States
Norfolk, Virginia 23510, United States
Spokane, Washington 99202, United States
