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

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Ciprofloxacin

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)