Skip to main content
OpenTrials
Completed

NCT Number: NCT00670215

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Salvador, Estado de Bahia, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Bacteriological Response (bacteriuria vs. no bacteriuria)

    Time frame: 10-14 days after last dose of study med

Secondary outcomes

  1. 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.

  2. Incidence of post-procedure GU tract infections other than bacteriuria

    Time frame: any time after the TRNBP

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2004
First posted
May 1, 2008
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.