Incidence of Fluoroquinolone Resistant Bacteria in Patients Undergoing Prostate Biopsy

Fluoroquinolone Resistant Enteric Bacteria Clinical Trial

Official title:

Incidence of Fluoroquinolone Resistant Bacteria in Patients Undergoing Prostate Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140502
• Other study ID #: Prostate Biopsy Infections
• Status: Completed
• Phase: N/A
• First received: May 1, 2014
• Last updated: May 16, 2017
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Fluoroquinolone Resistant Enteric Bacteria

Locations

Country	Name	City	State
Finland	Department of Urology, Meilahti Hospital	Helsinki	Uusimaa
Finland	Department of Urology, Peijas Hospital	Vantaa	Uusimaa

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Helsinki University, HUSLAB

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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