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Clinical Trials/NCT03040050
NCT03040050CompletedNot Applicable

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

The University of Texas Health Science Center at San Antonio1 site in 1 country38 target enrollmentStarted: January 1, 2017Last updated:
Conditions
Interventions

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

Other

Intervention: Control group (Other)

Men scheduled for a prostate biopsy randomized to Intervention

Experimental

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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