Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Phase 4

Completed

• Conditions: Infection
• Interventions: Drug: trimethoprim-sulfamethoxazole; Drug: Ciprofloxacin; Drug: cefuroxime; Drug: ceftriaxone; Drug: gentamicin; Drug: amikacin; Drug: aztreonam; Drug: imipenem

• Registration Number: NCT01659866
• Lead Sponsor: Northwestern University

Brief 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.

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 Timeline

• Study First Submitted: 2012-07-09
• Study Start: 2012-08
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-08
• Primary Completion: 2015-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Results First Submitted: 2016-09-23
• Results First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Results First Posted: 2019-06-25
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 563

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cipro-resistant	trimethoprim-sulfamethoxazole	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
Cipro-susceptible	Ciprofloxacin	Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy
Cipro-resistant	cefuroxime	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
Cipro-resistant	ceftriaxone	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
Cipro-resistant	aztreonam	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
Cipro-resistant	imipenem	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
Cipro-resistant	gentamicin	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
Cipro-resistant	amikacin	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Post-biopsy Infection.	30 days post-biopsy	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.

Trial Locations

Locations (1)

Northwestern University Department of Urology; 🇺🇸 Chicago, Illinois, United States