BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis
NCT ID: NCT00670215
Last Updated: 2014-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
497 participants
INTERVENTIONAL
2004-04-30
2004-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Arm 1
Ciprofloxacin single dose
Patients randomized to this regimen will receive a single-dose of ciprofloxacin MR 1000 mg PO approximately 2 to 3 hours prior to the TRNBP. Patients will also receive two doses of matching placebo approximately 24 hours prior to and approximately 24 hours after the TRNBP.
Arm 2
Ciprofloxacin triple dose
Patients randomized to this regimen will receive three doses of ciprofloxacin MR 1000 mg PO. The doses will be approximately 24 hours prior to the TRNBP, approximately 2 to 3 hours prior to the TRNBP, and approximately 24 hours after the TRNBP.
Interventions
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Ciprofloxacin single dose
Patients randomized to this regimen will receive a single-dose of ciprofloxacin MR 1000 mg PO approximately 2 to 3 hours prior to the TRNBP. Patients will also receive two doses of matching placebo approximately 24 hours prior to and approximately 24 hours after the TRNBP.
Ciprofloxacin triple dose
Patients randomized to this regimen will receive three doses of ciprofloxacin MR 1000 mg PO. The doses will be approximately 24 hours prior to the TRNBP, approximately 2 to 3 hours prior to the TRNBP, and approximately 24 hours after the TRNBP.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
San Diego, California, United States
San Francisco, California, United States
Sherman Oaks, California, United States
Waterbury, Connecticut, United States
Ocala, Florida, United States
Atlanta, Georgia, United States
Roswell, Georgia, United States
Chicago, Illinois, United States
Hopedale, Massachusetts, United States
New Brunswick, New Jersey, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Simpsonville, South Carolina, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Salvador, Estado de Bahia, Brazil
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
Rio de Janeiro, , Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Victoria, British Columbia, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Fleurimont, Quebec, Canada
Laval, Quebec, Canada
Québec, Quebec, Canada
Bergamo, , Italy
Milan, , Italy
Napoli, , Italy
Padua, , Italy
Roma, , Italy
Zapopan, Jalisco, Mexico
México D.F., Mexico, Mexico
Villahermosa, Tabasco, Mexico
México, D. F., , Mexico
México, D.F., , Mexico
Monterrey, , Mexico
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Vigo, Pontevedra, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain
Countries
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Other Identifiers
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100588
Identifier Type: -
Identifier Source: org_study_id