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

Completed · Not applicable

Conditions studied: Antibiotic Therapy, Prostate Biopsy

In brief

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.

Key facts

Study ID

NCT03040050

Run by

The University of Texas Health Science Center at San Antonio

People needed

38

Starts

2017-01-01

Expected to finish

2019-07-02

Last updated by the study team

2020-02-05

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• South Texas Veterans Health Care — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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