Fluoroquinolone Resistant Enteric Bacteria Clinical Trial
Official title:
Incidence of Fluoroquinolone Resistant Bacteria in Patients Undergoing Prostate Biopsy
Verified date | May 2017 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Finland | Department of Urology, Meilahti Hospital | Helsinki | Uusimaa |
Finland | Department of Urology, Peijas Hospital | Vantaa | Uusimaa |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital | Helsinki University, HUSLAB |
Finland,
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 |