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Completed

NCT Number: NCT03040050

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

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.

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Key information

Conditions

Antibiotic Therapy Prostate Biopsy

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

South Texas Veterans Health Care

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy.

    Time frame: Day of prostate biopsy

    Reduction in dual antibiotic prophylaxis in the intervention vs.usual care groups.

Secondary outcomes

  1. Determine if rapid qPCR test results in longer patient wait times.

    Time frame: Day of prostate biopsy

    Difference in the amount of time the PCR technique takes compared to the fastest workflow (physician chooses no additional antibiotics).

  2. Determine if rPCR results and standard rectal culture results are the same.

    Time frame: 1 week

    Comparison of rPCR results to standard rectal culture on Fluoroquinolone infused MacConkey agar.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 1, 2017
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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