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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00670215
First received: April 29, 2008
Last updated: June 19, 2009
Last verified: June 2009
History of Changes
  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).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • Incidence of post-procedure GU tract infections other than bacteriuria [ Time Frame: any time after the TRNBP ] [ Designated as safety issue: No ]

Enrollment: 438
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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/&#956;L. HIV testing is NOT required
  • Antibiotic administration within one week of the TRNBP
  • Severe hepatic insufficiency (Child-Pugh C)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670215

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

Additional Information:
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No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00670215     History of Changes
Other Study ID Numbers: 100588
Study First Received: April 29, 2008
Last Updated: June 19, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Bacterial Infections
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013