Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03040050|
Recruitment Status : Active, not recruiting
First Posted : February 1, 2017
Last Update Posted : June 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Antibiotic Therapy Prostate Biopsy||Other: rPCR results Other: Control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|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.|
|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|
|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.
- 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.
- 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).
- 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.
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
|United States, Texas|
|South Texas Veterans Health Care|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Michael Liss, MD||University of Texas Health Science Center San Antonio|