Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659866
• Other study ID #: STU00059558
• Secondary ID: EAM-237
• Status: Completed
• Phase: Phase 4
• Start date: August 2012
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• Ciprofloxacin
500 mg orally 2 hours before prostate biopsy
• 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
2 mg/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
5 mg/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

Locations

Country	Name	City	State
United States	Northwestern University Department of Urology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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