Clinical trial NCT02140502: Incidence of Fluoroquinolone Resistant Bacteria in Patients Undergoing Prostate Biopsy
Official title: Incidence of Fluoroquinolone Resistant Bacteria in Patients Undergoing Prostate Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluoroquinolone Resistant Enteric Bacteria
Keywords: Enterobacterial Infections
Prostate cancer
Biopsy
Incidence of fluoroquinolone resistant enteric bacteria
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: HUSLAB
First posted: 2014-05-16
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men undergoing prostate biopsy

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of fluoroquinolone resistant enteric bacteria
timeFrame: 14 days after rectal swab
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Urology, Meilahti Hospital
state: Uusimaa
city: Vantaa
country: Finland
facility: Department of Urology, Peijas Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Antti Rannikko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Henrikki Santti, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Kanerva Lahdensuo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.