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

NCT03040050 | Completed

• 1 other identifier: 16-386
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic Therapy; Prostate Biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Men scheduled for prostate biopsy randomized to Control

OTHER

Other: Control group

Men scheduled for a prostate biopsy randomized to Intervention

EXPERIMENTAL

Other: rPCR results

Interventions

rPCR results OTHER

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.

Men scheduled for a prostate biopsy randomized to Intervention

Control group OTHER

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.

Men scheduled for prostate biopsy randomized to Control

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

South Texas Veterans Health Care

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Michael Liss, MD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 1, 2017
• Study Start: January 1, 2017
• Primary Completion: August 24, 2018
• Study Completion: July 2, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

US (1)