Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Care Provider, Investigator)
  • Study Primary Completion Date: August 24, 2018

Interventions

  • Other: rPCR results
    • Interventional group: rPCR results will be shared with the clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care prostate biopsy.
  • Other: Control group
    • Control group: rPCR results will not be shared with the clinical provider at time of standard of care prostate biopsy. Standard of care antibiotic selection will be up to the discretion of the clinical provider.

Arms, Groups and Cohorts

  • Other: Men scheduled for prostate biopsy randomized to Control
  • Experimental: Men scheduled for a prostate biopsy randomized to Intervention

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Determine if rapid qPCR test results in longer patient wait times.
    • Time Frame: Day of prostate biopsy
    • Difference in the amount of time the PCR technique takes compared to the fastest workflow (physician chooses no additional antibiotics).
  • Determine if rPCR results and standard rectal culture results are the same.
    • Time Frame: 1 week
    • Comparison of rPCR results to standard rectal culture on Fluoroquinolone infused MacConkey agar.

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center at San Antonio
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael Liss, MD, Principal Investigator, University of Texas Health Science Center San Antonio

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