Antibiotic Prophylaxis for Transrectal Prostate Biopsy
Condition: Infection
MeSH terms: Infections
Intervention: Ciprofloxacin; trimethoprim-sulfamethoxazole; cefuroxime; ceftriaxone; gentamicin; amikacin; aztreonam; imipenem; ceftriaxone; gentamicin; amikacin; aztreonam; imipenem
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 563.0
Sex: Male
Minimum age: 30 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infection; Antibiotic resistance; Prostate biopsy

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.
    

Eligibility criteria:

        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