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

NCT00670215 | Completed Phase 3

• 1 other identifier: 100588
• Study Type: interventional
• Target: 497
• Locations: 6 countries
• Sites: 51

Brief Summary

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).

Conditions

Bacterial Infections

Keywords

Prevention of infectious complications; transrectal needle biopsies of the prostate; TRNBP

Outcome Measures

Primary Outcomes (1)

• Bacteriological Response (bacteriuria vs. no bacteriuria)

  10-14 days after last dose of study med

Secondary Outcomes (2)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Ciprofloxacin single dose

Arm 2

EXPERIMENTAL

Drug: Ciprofloxacin triple dose

Interventions

Ciprofloxacin single dose DRUG

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.

Arm 1

Ciprofloxacin triple dose DRUG

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.

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (51)

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Birmingham, Alabama, 35209, United States

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San Diego, California, 92101, United States

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San Francisco, California, 94117, United States

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Sherman Oaks, California, 91403, United States

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Waterbury, Connecticut, 06708, United States

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Ocala, Florida, 34474, United States

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Atlanta, Georgia, 30342, United States

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Roswell, Georgia, 30076, United States

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Chicago, Illinois, 60611, United States

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Hopedale, Massachusetts, 01747, United States

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New Brunswick, New Jersey, 08901, United States

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Cincinnati, Ohio, 45212-2787, United States

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Columbus, Ohio, 43214-1419, United States

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Philadelphia, Pennsylvania, 19107, United States

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Simpsonville, South Carolina, 29681, United States

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San Antonio, Texas, 78229, United States

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Norfolk, Virginia, 23510, United States

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Spokane, Washington, 99202, United States

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Salvador, Estado de Bahia, 41920 000, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Porto Alegre, Rio Grande do Sul, 90470 340, Brazil

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São Paulo, São Paulo, 04039-004, Brazil

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Rio de Janeiro, Brazil

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Calgary, Alberta, T2V 4R6, Canada

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Edmonton, Alberta, T6G 2C8, Canada

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Victoria, British Columbia, V8R 6T9, Canada

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Hamilton, Ontario, L8N 1T8, Canada

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Kingston, Ontario, K7L 2V7, Canada

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London, Ontario, N6A 4V2, Canada

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Toronto, Ontario, M4H 1C3, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Chicoutimi, Quebec, G7H 1H2, Canada

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Fleurimont, Quebec, J1H 5N4, Canada

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Laval, Quebec, H7G 2E6, Canada

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Québec, Quebec, G1S 2L6, Canada

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Bergamo, 24128, Italy

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Milan, 20132, Italy

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Napoli, 80131, Italy

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Padua, 35128, Italy

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Roma, 00155, Italy

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Zapopan, Jalisco, 45170, Mexico

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México D.F., Mexico, 06720, Mexico

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Villahermosa, Tabasco, 86158, Mexico

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México, D. F., 06700, Mexico

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México, D.F., 07760, Mexico

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Monterrey, 64320, Mexico

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Barcelona, Barcelona, 08035, Spain

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Madrid, Madrid, 28034, Spain

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Vigo, Pontevedra, 36214, Spain

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Seville, Sevilla, 41014, Spain

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Valencia, Valencia, 46009, Spain

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MeSH Terms

Conditions

Bacterial Infections

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: April 1, 2004
• Study Completion: October 1, 2004
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

ME (6); CA (12); US (18); BR (5); IT (5); ES (5)