Overview

This trial is active, not recruiting.

Condition infection
Treatments ciprofloxacin, trimethoprim-sulfamethoxazole, cefuroxime, ceftriaxone, gentamicin, amikacin, aztreonam, imipenem
Phase phase 4
Sponsor Northwestern University
Start date August 2012
End date August 2015
Trial size 540 participants
Trial identifier NCT01659866, EAM-237, STU00059558

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy
ciprofloxacin
500 mg orally 2 hours before prostate biopsy
(Active Comparator)
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
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

Primary Outcomes

Measure
Infection rates
time frame: 7 days post-biopsy

Secondary Outcomes

Measure
Infection rate
time frame: 30 days post-biopsy
Demographics and medical co-morbidities
time frame: Study day 1
Genus and species of rectal swab isolates with their antibiotic susceptibility profiles
time frame: Study day 7

Eligibility Criteria

Male participants from 30 years up to 90 years old.

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

Additional Information

Official title Evaluation of Directed Antimicrobial Prophylaxis for Transrectal Ultrasound Guided Prostate Biopsy (TRUSP)
Principal investigator Anthony J Schaeffer, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Northwestern University.