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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00670215

Enrollment

497

Registered

2008-05-01

Start date

2004-04-30

Completion date

2004-10-31

Last updated

2014-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

Keywords

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

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).

Interventions

DRUGCiprofloxacin 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.

DRUGCiprofloxacin 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

Brazil, Canada, Italy, Mexico, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026