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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00670215

Purpose

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).

Condition	Intervention	Phase
Bacterial Infections	Drug: Ciprofloxacin single dose Drug: Ciprofloxacin triple dose	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Bacteriological Response (bacteriuria vs. no bacteriuria) [ Time Frame: 10-14 days after last dose of study med ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]
Incidence of post-procedure GU tract infections other than bacteriuria [ Time Frame: any time after the TRNBP ] [ Designated as safety issue: No ]

Enrollment:	438
Study Start Date:	April 2004
Study Completion Date:	October 2004

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Ciprofloxacin 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.
Experimental: Arm 2	Drug: Ciprofloxacin 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670215

Show 51 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00670215 History of Changes
Other Study ID Numbers:	100588
Study First Received:	April 29, 2008
Last Updated:	June 19, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Prevention of infectious complications
transrectal needle biopsies of the prostate
TRNBP

Additional relevant MeSH terms:

Bacterial Infections
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012