Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.
Condition: Complication; Infection; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to assess the effectiveness and cost-effectiveness of rectal swab
      culture-guided antimicrobial prophylaxis to reduce infectious complications after transrectal
      prostate biopsy. Half of participants will receive routine empirical prophylaxis with oral
      ciprofloxacin (control group), while the other half will receive rectal culture-guided oral
      antibiotic prophylaxis (intervention group). In the intervention group, men whose rectal
      swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prophylaxis,
      comparable to the control group. In case of ciprofloxacin-resistant bacteria an alternative
      oral antibiotic based on the culture results will be prescribed
      (trimethoprim/sulfamethoxazole, fosfomycin or pivmecillinam/augmentin).

      The investigators hypothesise that the targeted prophylaxis group (intervention group) will
      have a lower rate of post-biopsy infectious complications compared to the control group.
    

Detailed description: 
      Several classes of antibiotics are proven effective for prophylaxis during transrectal
      prostate biopsy, reducing infectious complications to less than 1% in case of susceptible
      rectal flora. Ciprofloxacin has been best studied and is recommended as first choice
      prophylaxis in urology guidelines. However, due to increasing fluoroquinolone resistance in
      gram negative bacilli (currently more than 20% in E.coli), a significant increase up to 6% in
      infectious complications after transrectal prostate biopsy was recently noticed. Antibiotic
      treatment of these infections and hospitalization may account for increased health care
      associated costs and will contribute to the further development of antibiotic resistance.

      Besides, in urology guidelines no clear recommendations are made on the duration of
      prophylaxis. In the Netherlands, therefore, various prophylactic ciprofloxacin schedules are
      used, of which 2 to 3 day regimens are most common. Prolonged duration of prophylaxis during
      prostate biopsy is not proven to be more effective than a 1-day regimen, but it is more
      likely to select more fluoroquinolone (FQ) resistance.

      This study aims to assess the effectiveness and cost-effectiveness of rectal culture-guided
      antimicrobial prophylaxis to reduce infectious complications after transrectal prostate
      biopsy. Also, duration of antibiotic prophylaxis will be minimized to 24 hours, thereby
      controlling further development of resistant bacteria.

      The culture method used in this study with four phenotypic screening agars to support the
      choice of one of the oral prophylactic antibiotics is innovative. Culture results become
      available rapidly, within 48 hours, the method is simple, relatively inexpensive, as it does
      not need full susceptibility testing of separate colonies, and useful in daily practice.
    

Intervention name(s): Ciprofloxacin; Trimethoprim/Sulfamethoxazole; Fosfomycin; Pivmecillinam/augmentin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): see study arms.; see study arms.; see study arms.; see study arms.
Other intervention name(s): Ciproxin; Co-trimoxazole; Monuril; Selexid; Amoxicillin/clavulanic acid
Intervention MeSH terms: Amoxicillin; Ciprofloxacin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acids; Clavulanic Acid; Fosfomycin; Trimethoprim, Sulfamethoxazole Drug Combination; Amdinocillin Pivoxil; Trimethoprim; Sulfamethoxazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Culture-guided; Targeted prophylaxis; Prostate biopsy; Antibiotic prophylaxis