Antibiotic Prophylaxis for Transrectal Prostate Biopsy
|ClinicalTrials.gov Identifier: NCT01659866|
Recruitment Status : Unknown
Verified January 2016 by Anthony Schaeffer, Northwestern University.
Recruitment status was: Active, not recruiting
First Posted : August 8, 2012
Last Update Posted : January 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Infection||Drug: Ciprofloxacin Drug: trimethoprim-sulfamethoxazole Drug: cefuroxime Drug: ceftriaxone Drug: gentamicin Drug: amikacin Drug: aztreonam Drug: imipenem||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Directed Antimicrobial Prophylaxis for Transrectal Ultrasound Guided Prostate Biopsy (TRUSP)|
|Study Start Date :||August 2012|
|Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2016|
Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy
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:
1 double strength tablet orally 2 hours before the procedure and again 12 hours laterDrug: cefuroxime
500 mg orally 2 hours before the procedure then again 12 hours laterDrug: ceftriaxone
500 mg intramuscularly 2 hours before the procedureDrug: gentamicin
2 mg/kg intramuscularly 2 hours before the procedureDrug: amikacin
5 mg/kg intramuscularly 2 hours before the procedureDrug: aztreonam
500 mg intramuscularly 2 hours before the procedureDrug: imipenem
500 mg intramuscularly 2 hours before the procedureDrug: ceftriaxone
2000 mg intravenously 1 hour before the procedureDrug: gentamicin
2 mg/kg intravenously 1 hour before the procedureDrug: amikacin
5 mg/kg intravenously 1 hour before the procedureDrug: aztreonam
2000 mg intravenously 1 hour before the procedureDrug: imipenem
1000 mg intravenously 1 hour before the procedure
- Infection rates [ Time Frame: 7 days post-biopsy ]To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB
- Infection rate [ Time Frame: 30 days post-biopsy ]To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB
- Demographics and medical co-morbidities [ Time Frame: Study day 1 ]Certain demographics and medical co-morbidities may predispose to infection following prostate biopsy. As such, these will be measured and compared among the ciprofloxacin susceptible and resistant groups. The demographics include age and ethnicity and the co-morbidities include reason for biopsy, past exposure to antibiotics within 2 years of the biopsy, exposure to a healthcare facility within the last year, any prior infection after prostate biopsy, and history of urinary traction infection or urinary retention.
- Genus and species of rectal swab isolates with their antibiotic susceptibility profiles [ Time Frame: Study day 7 ]
- Cost of care [ Time Frame: 30 days post-biopsy ]To determine and compare the overall cost of care among the two groups
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659866
|United States, Illinois|
|Northwestern University Department of Urology|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Anthony J Schaeffer, MD||Northwestern University|