Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Evaluation of Directed Antimicrobial Prophylaxis for Transrectal Ultrasound Guided Prostate Biopsy (TRUSP)

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.

Study Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Drug: Ciprofloxacin; Drug: trimethoprim-sulfamethoxazole; Drug: cefuroxime; Drug: ceftriaxone; Drug: gentamicin; Drug: amikacin; Drug: aztreonam; Drug: imipenem; Drug: ceftriaxone; Drug: gentamicin; Drug: amikacin; Drug: aztreonam; Drug: imipenem

Detailed Description

This study is a prospective, nonrandomized trial evaluating the efficacy of directed antimicrobial prophylaxis prior to transrectal ultrasound-guided prostate biopsy (TRUSP) compared with ciprofloxacin prophylaxis, the current standard of care. Northwestern University will be the lead site. After signing informed consent, study participants will complete a pre-biopsy questionnaire to record demographics and assess for known risk factors for infection and will have a rectal swab obtained. Patients whose swabs indicate colonization with ciprofloxacin-susceptible gram-negative bacteria (CS-GNB) will receive ciprofloxacin as pre-procedure prophylaxis and those whose swabs indicate colonization with ciprofloxacin-resistant gram-negative bacteria (CR-GNB) will receive pre-procedure antimicrobial prophylaxis based on study protocol.

All patients will be contacted by phone twice after their biopsies, at approximately 7 and 30 days, to detail post-procedure infectious complications including fever, urinary tract infection, bacteremia and sepsis. Subjects who experience infections will have additional information regarding the infectious complications and cost of therapy abstracted from their medical record. The TRUSP results will also be recorded. Bacterial isolates from the rectal swabs will be archived.

• Study Type: Interventional
• Enrollment (Actual): 563
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Department of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Ability and willingness to provide written informed consent.
• All individuals who will undergo TRUSP as part of their standard of care are eligible for study.

Exclusion Criteria:

• Men under 30 years of age
• Individuals whose rectal swab indicates that they harbor CS-GNB who cannot receive ciprofloxacin as pre-procedure prophylaxis for any reason
• Individuals whose rectal swab indicates that they harbor CR-GNB who cannot abide by the antimicrobial prophylaxis guidelines outlined in the study protocol for any reason
• Individuals who do not wish to complete the pre-procedure risk factor questionnaire or the two post-procedure phone questionnaires to assess for infectious complications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cipro-susceptible; Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy	Drug: Ciprofloxacin; 500 mg orally 2 hours before prostate biopsy
Active Comparator: Cipro-resistant; Patients with ciprofloxacin-resistant bacteria on their rectal swab will receive one of the following drugs: trimethoprim-sulfamethoxazole 1 double strength tablet orally 2 hours before the procedure and again 12 hours later; cefuroxime 500 mg orally 2 hours before the procedure then again 12 hours later; ceftriaxone 500 mg intramuscularly 2 hours before the procedure; gentamicin 2mg/kg intramuscularly 2 hours before the procedure; amikacin 5 mg/kg intramuscularly 2 hours before the procedure; aztreonam 500 mg intramuscularly 2 hours before the procedure; imipenem 500 mg intramuscularly 2 hours before the procedure; ceftriaxone 2000 mg intravenously 1 hour before the procedure; gentamicin 2 mg/kg intravenously 1 hour before the procedure; amikacin 5mg/kg intravenously 1 hour before the procedure; aztreonam 2000 mg intravenously 1 hour before the procedure; imipenem 1000 mg intravenously 1 hour before the procedure	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Post-biopsy Infection.	To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB. This measure is number of participants with post-biopsy infection.	30 days post-biopsy

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Anthony J Schaeffer, MD, Northwestern University

Publications and helpful links

General Publications

• Zembower TR, Maxwell KM, Nadler RB, Cashy J, Scheetz MH, Qi C, Schaeffer AJ. Evaluation of targeted antimicrobial prophylaxis for transrectal ultrasound guided prostate biopsy: a prospective cohort trial. BMC Infect Dis. 2017 Jun 7;17(1):401. doi: 10.1186/s12879-017-2470-1.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 8, 2012

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Infection; Prostate biopsy; Antibiotic resistance
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Dyskinesia Agents; Anti-Infective Agents, Urinary; Renal Agents; Cytochrome P-450 CYP2C8 Inhibitors; Ceftriaxone; Gentamicins; Ciprofloxacin; Imipenem; Trimethoprim; Sulfamethoxazole; Trimethoprim, Sulfamethoxazole Drug Combination; Aztreonam; Amikacin; Cefuroxime
• Other Study ID Numbers: STU00059558; EAM-237 (Other Identifier: Excellence in Academic Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes