Incidence of Fluoroquinolone Resistant Bacteria in Patients Undergoing Prostate Biopsy

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.

Study Overview

• Status: Completed
• Conditions: Fluoroquinolone Resistant Enteric Bacteria

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00290
      • Department of Urology, Meilahti Hospital
    • Vantaa, Uusimaa, Finland, 01400
      • Department of Urology, Peijas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men undergoing prostate biopsy

Description

Inclusion Criteria:

• clinical suspicion of prostate cancer or previous diagnosis of prostate cancer
• must be able to give informed consent

Exclusion Criteria:

• uncontrolled serious infection
• uncontrolled hemorrhagic disorder
• rectal swab sample not possible

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Men undergoing prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of fluoroquinolone resistant enteric bacteria	The rectal swabs will be cultured in mediums that contain fluoroquinolones (FQ) to assess whether FQ-resistant bacterial strains emerge. The culture findings will be evaluated 14 days after obtaining the samples. The number of participants with FQ-resistant enteric bacteria is analyzed.	14 days after rectal swab

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki; HUSLAB
• Investigators: Principal Investigator: Antti Rannikko, MD, PhD, Helsinki University Central Hospital; Principal Investigator: Henrikki Santti, M.D., PhD, Helsinki University Central Hospital; Principal Investigator: Kanerva Lahdensuo, M.D., Helsinki University Central Hospital

Publications and helpful links

General Publications

• Kalalahti I, Huotari K, Lahdensuo K, Tarkka E, Santti H, Rannikko A, Patari-Sampo A. Rectal E. coli above ciprofloxacin ECOFF associate with infectious complications following prostate biopsy. Eur J Clin Microbiol Infect Dis. 2018 Jun;37(6):1055-1060. doi: 10.1007/s10096-018-3217-7. Epub 2018 Mar 2.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 1, 2014
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimate): May 16, 2014

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Prostate cancer; Biopsy; Enterobacterial Infections; Incidence of fluoroquinolone resistant enteric bacteria
• Other Study ID Numbers: Prostate Biopsy Infections