Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men scheduled for prostate biopsy randomized to Control | Other |
| |
| Men scheduled for a prostate biopsy randomized to Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Determine if rPCR results and standard rectal culture results are the same. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Liss, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Veterans Health Care | San Antonio | Texas | 78229 | United States |
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 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. |
|
Comparison of rPCR results to standard rectal culture on Fluoroquinolone infused MacConkey agar. |
| 1 week |
| D008722 | Methods |