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

Prostate Biopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040050
• Other study ID #: 16-386
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: July 2, 2019

Study information

• Verified date: February 2020
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2, 2019
• Est. primary completion date: August 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Therapy
• Prostate Biopsy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	South Texas Veterans Health Care	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy.	Reduction in dual antibiotic prophylaxis in the intervention vs.usual care groups.	Day of prostate biopsy
Secondary	Determine if rapid qPCR test results in longer patient wait times.	Difference in the amount of time the PCR technique takes compared to the fastest workflow (physician chooses no additional antibiotics).	Day of prostate biopsy
Secondary	Determine if rPCR results and standard rectal culture results are the same.	Comparison of rPCR results to standard rectal culture on Fluoroquinolone infused MacConkey agar.	1 week