Incidence of Fluoroquinolone Resistant Bacteria in Patients Undergoing Prostate Biopsy
Condition: Fluoroquinolone Resistant Enteric Bacteria
Study type: Observational [Patient Registry]

Summary: 
      In this study, the investigators aim to establish the incidence of enteric fluoroquinolone
      resistant bacteria in a contemporary clinical cohort. This incidence will be studied by
      taking a rectal swab sample from all consenting patients coming in for prostate biopsies. The
      information gained from this study will be used to determine whether antibiotic prophylactic
      practices need to be updated in their clinic. The investigators aim to enroll 200 patients
      and patient recruitment is estimated to take place between May 2014 and August 2014. The
      study is estimated to end in May 2016.
    

Detailed description: 
      Due to prostate-specific antigen (PSA) screening and the aging population in many Western
      countries, prostate biopsies to detect prostate cancer are being taken more and more often.
      Prostate biopsies are also performed in the surveillance of prostate cancer. In most cases,
      biopsies are taken trans-rectally with ultrasound guidance. Due to the trans-rectal route,
      there is an inherent risk of infectious complications. These complications range from minor
      complications, such as bacteriuria and epididymitis, to severe complications requiring
      intensive care such as sepsis. The rate of these most severe complications has long been
      estimated at 1-2 %, but a steady rise has been observed since the beginning of the 21st
      century, with some centers reporting occurrence rates as high as 8%. Interestingly, the rate
      of other complications related to this procedure (e.g. rectal bleeding, hematuria,
      hematospermia, dysuria) have remained constant. Prophylactic antibiotics are routinely
      administered to minimize the rate of infectious complications. The most commonly used
      prophylactic antibiotic agents are fluoroquinolones (FQ). The observed rise in the rate of
      severe complications has been attributed to emerging strains of FQ-resistant bacteria. Known
      risk factors for harboring enteric resistant bacterial strains are recent (within three
      months) antibiotic use and travel to areas where these bacterial strains are known to be
      endemic. When a patient is known to harbor FQ-resistant enterobacteria, a different
      prophylactic antibiotic should be chosen. In this study, the investigators aim to
      prospectively establish the incidence of enteric FQ-resistant bacteria in a clinical patient
      cohort. This incidence will be studied by taking a rectal swab sample from all consenting
      patients coming in for prostate biopsies. The information gained from this study will be used
      mainly to determine whether antibiotic prophylactic practices need to be updated in their
      clinic. The investigators aim to enroll 200 patients and patient recruitment is estimated to
      take place between May 2014 and August 2014. The study is estimated to end in May 2016.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men undergoing prostate biopsy
      
Biospecimen description: 
      rectal culture swabs
    
Keywords: Enterobacterial Infections; Prostate cancer; Biopsy; Incidence of fluoroquinolone resistant enteric bacteria