Prostate Biopsy Clinical Trial
Official title:
Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy
NCT number | NCT03040050 |
Other study ID # | 16-386 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | July 2, 2019 |
Verified date | February 2020 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | July 2, 2019 |
Est. primary completion date | August 24, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 50 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | South Texas Veterans Health Care | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Determine if rapid qPCR test results in longer patient wait times. | Difference in the amount of time the PCR technique takes compared to the fastest workflow (physician chooses no additional antibiotics). | Day of prostate biopsy | |
Secondary | Determine if rPCR results and standard rectal culture results are the same. | Comparison of rPCR results to standard rectal culture on Fluoroquinolone infused MacConkey agar. | 1 week |
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