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

Not Applicable

Completed

• Conditions: Antibiotic Therapy; Prostate Biopsy
• Interventions: Other: rPCR results; Other: Control group

• Registration Number: NCT03040050
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Primary Completion: 2018-08-24
• Study Completion: 2019-07-02
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Men scheduled for a prostate biopsy randomized to Intervention	rPCR results	-
Men scheduled for prostate biopsy randomized to Control	Control group	-

Primary Outcome Measures

Name	Time	Method
Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy.	Day of prostate biopsy	Reduction in dual antibiotic prophylaxis in the intervention vs.usual care groups.

Secondary Outcome Measures

Name	Time	Method
Determine if rapid qPCR test results in longer patient wait times.	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.	1 week	Comparison of rPCR results to standard rectal culture on Fluoroquinolone infused MacConkey agar.

Trial Locations

Locations (1)

South Texas Veterans Health Care; 🇺🇸 San Antonio, Texas, United States