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

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”

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).

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Experimental: Arm 2

Primary Measures

• Bacteriological Response (bacteriuria vs. no bacteriuria)
  • Time Frame: 10-14 days after last dose of study med
    Safety Issue?: No

Secondary 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.
    Safety Issue?: No
• Incidence of post-procedure GU tract infections other than bacteriuria
  • Time Frame: any time after the TRNBP
    Safety Issue?: 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/&#956;L. HIV testing is NOT required
• Antibiotic administration within one week of the TRNBP
• Severe hepatic insufficiency (Child-Pugh C)

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00670215

Study ID Number: 100588

ClinicalTrials.gov Identifier: NCT00670215

Health Authority: United States: Food and Drug Administration

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