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

Phase 3

Completed

• Conditions: Bacterial Infections
• Interventions: Drug: Ciprofloxacin single dose; Drug: Ciprofloxacin triple dose

• Registration Number: NCT00670215
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study Completion: 2004-10
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-04-29
• Study First Posted: 2008-05-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 497

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Ciprofloxacin single dose	-
Arm 2	Ciprofloxacin triple dose	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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