Clinical trial NCT01659866
Conditions: Infection
Keywords: Infection Antibiotic resistance Prostate biopsy
Sponsor: Northwestern University
Start date: 2012-08-01; Completion date: 2016-08-01
Enrollment: 563 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy arm 2: 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
Interventions: intervention 1: Ciprofloxacin intervention 2: trimethoprim-sulfamethoxazole intervention 3: cefuroxime intervention 4: ceftriaxone intervention 5: gentamicin intervention 6: amikacin intervention 7: aztreonam intervention 8: imipenem intervention 9: ceftriaxone intervention 10: gentamicin intervention 11: amikacin intervention 12: aztreonam intervention 13: imipenem
Intervention descriptions: intervention 1: 500 mg orally 2 hours before prostate biopsy intervention 2: 1 double strength tablet orally 2 hours before the procedure and again 12 hours later intervention 3: 500 mg orally 2 hours before the procedure then again 12 hours later intervention 4: 500 mg intramuscularly 2 hours before the procedure intervention 5: 2 mg/kg intramuscularly 2 hours before the procedure intervention 6: 5 mg/kg intramuscularly 2 hours before the procedure intervention 7: 500 mg intramuscularly 2 hours before the procedure intervention 8: 500 mg intramuscularly 2 hours before the procedure intervention 9: 2000 mg intravenously 1 hour before the procedure intervention 10: 2 mg/kg intravenously 1 hour before the procedure intervention 11: 5 mg/kg intravenously 1 hour before the procedure intervention 12: 2000 mg intravenously 1 hour before the procedure intervention 13: 1000 mg intravenously 1 hour before the procedure

Protocol documents: