Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy.
Study Overview
Brief Summary
The study is a randomized controlled trial. Subjects are randomly assigned 1:1 to receive either rapid multiplex qPCR (intervention) prior to standard of care prostate biopsy or standard of care (control) prostate biopsy. The subjects will have a rectal culture swab performed prior to the prostate biopsy. One rectal culture swab will be used for rapid multiplex qPCR and the other swab will be sent to microbiology for a standard culture. The subjects randomized to the intervention group will have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. The subjects randomized to the control group will not have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. Approximately, 10 days after the prostate biopsy, the research staff will conduct a chart review and/or telephone call to ask about any prostate biopsy infections and complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Double (Care Provider, Investigator)
Masking Description
The rPCR results will be provided to the clinical provider for the Interventional group participants. The rPCR results will not be provided to the clinic provider for the control group participants.
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be able to give informed consent
- •Be age 50 or older
- •Recommended to undergo a prostate biopsy
- •No allergy or side effect to fluoroquinolone antibiotics
- •No history of prostate biopsy infection
- •No hepatic or renal insufficiency in which fluoroquinolone antibiotics are contraindicated.
Exclusion Criteria
- •Unable to give informed consent
- •Age < 50
- •Not recommended to have prostate biopsy
- •Allergic to or have side effects to fluoroquinolone antibiotics
- •History of prostate biopsy infection
- •Hepatic or renal insufficiency in which fluoroquinolones antibiotics are contraindicated.
Arms & Interventions
Men scheduled for prostate biopsy randomized to Control
Intervention: Control group (Other)
Men scheduled for a prostate biopsy randomized to Intervention
Intervention: rPCR results (Other)
Outcomes
Primary Outcomes
Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy.
Time Frame: Day of prostate biopsy
Reduction in dual antibiotic prophylaxis in the intervention vs.usual care groups.
Secondary Outcomes
- Determine if rapid qPCR test results in longer patient wait times.(Day of prostate biopsy)
- Determine if rPCR results and standard rectal culture results are the same.(1 week)
