Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 29, 2008
Last updated: December 18, 2014
Last verified: December 2014
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).

Condition Intervention Phase
Bacterial Infections
Drug: Ciprofloxacin single dose
Drug: Ciprofloxacin triple dose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Bacteriological Response (bacteriuria vs. no bacteriuria) [ Time Frame: 10-14 days after last dose of study med ]

Secondary Outcome Measures:
  • Clinical Response (patients without clinical symptoms or signs of bacteriuria vs. patients with clinical symptoms or signs of bacteriuria) [ Time Frame: 10-14 days after last dose of study med. ]
  • Incidence of post-procedure GU tract infections other than bacteriuria [ Time Frame: any time after the TRNBP ]

Enrollment: 497
Study Start Date: April 2004
Study Completion Date: October 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: 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.
Experimental: Arm 2 Drug: 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00670215

  Show 51 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00670215     History of Changes
Other Study ID Numbers: 100588
Study First Received: April 29, 2008
Last Updated: December 18, 2014

Keywords provided by Bayer:
Prevention of infectious complications
transrectal needle biopsies of the prostate

Additional relevant MeSH terms:
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on May 22, 2017