Incidence of Fluoroquinolone Resistant Bacteria in Patients Undergoing Prostate Biopsy

NCT ID: NCT02140502

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-12-31

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.

Conditions

Fluoroquinolone Resistant Enteric Bacteria

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Men undergoing prostate biopsy

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

HUSLAB

UNKNOWN

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kanerva Lahdensuo

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antti Rannikko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Henrikki Santti, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Kanerva Lahdensuo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Department of Urology, Meilahti Hospital

Helsinki, Uusimaa, Finland

Department of Urology, Peijas Hospital

Vantaa, Uusimaa, Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 29500572 (View on PubMed)

Other Identifiers

Prostate Biopsy Infections

Identifier Type: -

Identifier Source: org_study_id