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

The University of Texas System (UT)

Status: Completed

Conditions: Prostate Biopsy; Antibiotic Therapy

Treatments: Other: rPCR results; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03040050

16-386

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: Male

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Men scheduled for prostate biopsy randomized to Control

Other group

Treatment:

Other: Control group

Men scheduled for a prostate biopsy randomized to Intervention

Experimental group

Treatment:

Other: rPCR results