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

Study Overview
=================
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).

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

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Ciprofloxacin single dose
* Drug: Ciprofloxacin triple dose


Participation Criteria
=================
Eligibility 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/micL. HIV testing is NOT required Antibiotic administration within one week of the TRNBP Severe hepatic insufficiency (Child-Pugh C)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Ciprofloxacin single dose<br>* 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.<br>|
| Experimental: Arm 2<br> | Drug: Ciprofloxacin triple dose<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of infectious complications, transrectal needle biopsies of the prostate, TRNBP