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

Bayer

Status and phase

Completed

Phase 3

Conditions

Bacterial Infections

Treatments

Drug: Ciprofloxacin triple dose

Drug: Ciprofloxacin single dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT00670215

100588

Details and patient eligibility

About

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).

Enrollment

497 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)