Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Summary

This study is being conducted in men scheduled to undergo transrectal ultrasound-guided prostate biopsy (TRUSP). Traditionally prior to prostate biopsy, an antibiotic, ciprofloxacin, has been given to men to prevent biopsy-related infections. In recent years as ciprofloxacin resistance has increased in the community, more and more men are becoming infected with ciprofloxacin-resistant bacteria after prostate biopsy. This study is being done to determine if obtaining rectal swab cultures and choosing antibiotics based on these culture results will result in fewer infectious complications than giving all men ciprofloxacin.

The investigators will compare 2 groups: men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prior to biopsy, and men whose swabs do show ciprofloxacin-resistant bacteria will receive alternative antibiotics based on their culture results. Our hypothesis is that these 2 groups will have equal numbers of post-biopsy infectious complications and both groups will have fewer infectious complications than a historical group who received empiric ciprofloxacin without the benefit of rectal swab culture results.

Conditions

• Infection

Interventions

DRUG

Ciprofloxacin

500 mg orally 2 hours before prostate biopsy

DRUG

trimethoprim-sulfamethoxazole

1 double strength tablet orally 2 hours before the procedure and again 12 hours later

DRUG

cefuroxime

500 mg orally 2 hours before the procedure then again 12 hours later

DRUG

ceftriaxone

500 mg intramuscularly 2 hours before the procedure

DRUG

gentamicin

2 mg/kg intramuscularly 2 hours before the procedure

DRUG

amikacin

5 mg/kg intramuscularly 2 hours before the procedure

DRUG

aztreonam

500 mg intramuscularly 2 hours before the procedure

DRUG

imipenem

500 mg intramuscularly 2 hours before the procedure

DRUG

ceftriaxone

2000 mg intravenously 1 hour before the procedure

DRUG

gentamicin

2 mg/kg intravenously 1 hour before the procedure

DRUG

amikacin

5 mg/kg intravenously 1 hour before the procedure

DRUG

aztreonam

2000 mg intravenously 1 hour before the procedure

DRUG

imipenem

1000 mg intravenously 1 hour before the procedure

Sponsors & Collaborators

• Northwestern University

  lead OTHER

Principal Investigators

• Anthony J Schaeffer, MD · Northwestern University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

90 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2015-08-31

Completion

2016-08-31

Countries

• United States

Study Locations