Antibiotic Prophylaxis for Transrectal Prostate Biopsy
Condition: Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Ciprofloxacin; trimethoprim-sulfamethoxazole; cefuroxime; ceftriaxone; gentamicin; amikacin; aztreonam; imipenem; ceftriaxone; gentamicin; amikacin; aztreonam; imipenem
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 500 mg orally 2 hours before prostate biopsy; 1 double strength tablet orally 2 hours before the procedure and again 12 hours later; 500 mg orally 2 hours before the procedure then again 12 hours later; 500 mg intramuscularly 2 hours before the procedure; 2 mg/kg intramuscularly 2 hours before the procedure; 5 mg/kg intramuscularly 2 hours before the procedure; 500 mg intramuscularly 2 hours before the procedure; 500 mg intramuscularly 2 hours before the procedure; 2000 mg intravenously 1 hour before the procedure; 2 mg/kg intravenously 1 hour before the procedure; 5 mg/kg intravenously 1 hour before the procedure; 2000 mg intravenously 1 hour before the procedure; 1000 mg intravenously 1 hour before the procedure
Intervention MeSH terms: Ciprofloxacin; Gentamicins; Ceftriaxone; Imipenem; Amikacin; Cefuroxime; Trimethoprim, Sulfamethoxazole Drug Combination; Aztreonam; Trimethoprim; Sulfamethoxazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infection; Antibiotic resistance; Prostate biopsy