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

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ClinicalTrials.gov Identifier: NCT03040050
Recruitment Status : Active, not recruiting
First Posted : February 1, 2017
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment Phase
Antibiotic Therapy Prostate Biopsy Other: rPCR results Other: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Biopsy

Arm Intervention/treatment
Men scheduled for prostate biopsy randomized to Control Other: 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.

Experimental: Men scheduled for a prostate biopsy randomized to 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040050


Locations
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United States, Texas
South Texas Veterans Health Care
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Michael Liss, MD University of Texas Health Science Center San Antonio

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03040050     History of Changes
Other Study ID Numbers: 16-386
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents