BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00670215
First received: April 29, 2008
Last updated: June 19, 2009
Last verified: June 2009
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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:
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/μL. 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
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Hide Study LocationsLocations
| United States, Alabama | |
| Birmingham, Alabama, United States, 35209 | |
| United States, California | |
| San Diego, California, United States, 92101 | |
| San Francisco, California, United States, 94117 | |
| Sherman Oaks, California, United States, 91403 | |
| United States, Connecticut | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| Ocala, Florida, United States, 34474 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30342 | |
| Roswell, Georgia, United States, 30076 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60611 | |
| United States, Massachusetts | |
| Hopedale, Massachusetts, United States, 01747 | |
| United States, New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45212-2787 | |
| Columbus, Ohio, United States, 43214-1419 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Simpsonville, South Carolina, United States, 29681 | |
| United States, Texas | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Norfolk, Virginia, United States, 23510 | |
| United States, Washington | |
| Spokane, Washington, United States, 99202 | |
| Brazil | |
| Salvador, Bahia, Brazil, 41920 000 | |
| Belo Horizonte, Minas Gerais, Brazil | |
| Porto Alegre, RS, Brazil, 90470 340 | |
| Rio de Janeiro, Brazil | |
| São Paulo, Brazil, 04039-004 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2V 4R6 | |
| Edmonton, Alberta, Canada, T6G 2C8 | |
| Canada, British Columbia | |
| Victoria, British Columbia, Canada, V8R 6T9 | |
| Canada, Ontario | |
| Hamilton, Ontario, Canada, L8N 1T8 | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| London, Ontario, Canada, N6A 4V2 | |
| Toronto, Ontario, Canada, M4H 1C3 | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Chicoutimi, Quebec, Canada, G7H 1H2 | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| Laval, Quebec, Canada, H7G 2E6 | |
| Canada | |
| Quebec, Canada, G1S 2L6 | |
| Italy | |
| Bergamo, Italy, 24128 | |
| Milano, Italy, 20132 | |
| Napoli, Italy, 80131 | |
| Padova, Italy, 35128 | |
| Roma, Italy, 00155 | |
| Mexico | |
| Zapopan, Jalisco, Mexico, 45170 | |
| Villahermosa, Tabasco, Mexico, 86158 | |
| Monterrey, Mexico, 64320 | |
| México D.F., Mexico, 06720 | |
| México, D. F., Mexico, 06700 | |
| México, D.F., Mexico, 07760 | |
| Spain | |
| Vigo, Pontevedra, Spain, 36214 | |
| Barcelona, Spain, 08035 | |
| Madrid, Spain, 28034 | |
| Sevilla, Spain, 41014 | |
| Valencia, Spain, 46009 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
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 May 21, 2013