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

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).

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: Ciprofloxacin single dose; Drug: Ciprofloxacin triple dose

• Study Type: Interventional
• Enrollment (Actual): 497
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil
  • São Paulo, Brazil, 04039-004
  • Bahia
    • Salvador, Bahia, Brazil, 41920 000
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90470 340
• Canada
  • Quebec, Canada, G1S 2L6
  • Alberta
    • Calgary, Alberta, Canada, T2V 4R6
    • Edmonton, Alberta, Canada, T6G 2C8
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 6T9
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1T8
    • Kingston, Ontario, Canada, K7L 2V7
    • London, Ontario, Canada, N6A 4V2
    • Toronto, Ontario, Canada, M4N 3M5
    • Toronto, Ontario, Canada, M4H 1C3
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 1H2
    • Fleurimont, Quebec, Canada, J1H 5N4
    • Laval, Quebec, Canada, H7G 2E6
• Italy
  • Bergamo, Italy, 24128
  • Milano, Italy, 20132
  • Napoli, Italy, 80131
  • Padova, Italy, 35128
  • Roma, Italy, 00155
• Mexico
  • Monterrey, Mexico, 64320
  • México D.F., Mexico, 06720
  • México, D. F., Mexico, 06700
  • México, D.F., Mexico, 07760
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45170
  • Tabasco
    • Villahermosa, Tabasco, Mexico, 86158
• Spain
  • Barcelona, Spain, 08035
  • Madrid, Spain, 28034
  • Sevilla, Spain, 41014
  • Valencia, Spain, 46009
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36214
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
  • California
    • San Diego, California, United States, 92101
    • San Francisco, California, United States, 94117
    • Sherman Oaks, California, United States, 91403
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
  • Florida
    • Ocala, Florida, United States, 34474
  • Georgia
    • Atlanta, Georgia, United States, 30342
    • Roswell, Georgia, United States, 30076
  • Illinois
    • Chicago, Illinois, United States, 60611
  • Massachusetts
    • Hopedale, Massachusetts, United States, 01747
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
  • Ohio
    • Cincinnati, Ohio, United States, 45212-2787
    • Columbus, Ohio, United States, 43214-1419
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
  • South Carolina
    • Simpsonville, South Carolina, United States, 29681
  • Texas
    • San Antonio, Texas, United States, 78229
  • Virginia
    • Norfolk, Virginia, United States, 23510
  • Washington
    • Spokane, Washington, United States, 99202

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bacteriological Response (bacteriuria vs. no bacteriuria)	10-14 days after last dose of study med

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: April 29, 2008
• First Submitted That Met QC Criteria: April 29, 2008
• First Posted (Estimate): May 1, 2008

Study Record Updates

• Last Update Posted (Estimate): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 18, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Prevention of infectious complications; transrectal needle biopsies of the prostate; TRNBP
• Additional Relevant MeSH Terms: Bacterial Infections and Mycoses; Infections; Bacterial Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 100588