Back to resultsBAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis
Primary Purpose
Bacterial Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ciprofloxacin single dose
Ciprofloxacin triple dose
Sponsored by
About this trial
This is an interventional prevention trial for Bacterial Infections focused on measuring Prevention of infectious complications, transrectal needle biopsies of the prostate, TRNBP
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Bacteriological Response (bacteriuria vs. no bacteriuria)
Secondary Outcome Measures
Clinical Response (patients without clinical symptoms or signs of bacteriuria vs. patients with clinical symptoms or signs of bacteriuria)
Incidence of post-procedure GU tract infections other than bacteriuria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00670215
Brief Title
BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
Prevention of infectious complications, transrectal needle biopsies of the prostate, TRNBP
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
497 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin single dose
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin triple dose
Intervention Description
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 Outcome Measure Information:
Title
Bacteriological Response (bacteriuria vs. no bacteriuria)
Time Frame
10-14 days after last dose of study med
Secondary Outcome Measure Information:
Title
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.
Title
Incidence of post-procedure GU tract infections other than bacteriuria
Time Frame
any time after the TRNBP
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Hopedale
State/Province
Massachusetts
ZIP/Postal Code
01747
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212-2787
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-1419
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41920 000
Country
Brazil
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90470 340
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
São Paulo
ZIP/Postal Code
04039-004
Country
Brazil
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4R6
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6T9
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1T8
Country
Canada
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4H 1C3
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 1H2
Country
Canada
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7G 2E6
Country
Canada
City
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Roma
ZIP/Postal Code
00155
Country
Italy
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45170
Country
Mexico
City
Villahermosa
State/Province
Tabasco
ZIP/Postal Code
86158
Country
Mexico
City
Monterrey
ZIP/Postal Code
64320
Country
Mexico
City
México D.F.
ZIP/Postal Code
06720
Country
Mexico
City
México, D. F.
ZIP/Postal Code
06700
Country
Mexico
City
México, D.F.
ZIP/Postal Code
07760
Country
Mexico
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36214
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis
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