Antibiotic TherapyNCT03040050
Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy
A study testing rPCR results in people with Antibiotic Therapy and Prostate Biopsy, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Therapy, Prostate Biopsy
- What is being tested?
- rPCR results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 2 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Veterans Health Care
San Antonio, Texas, 78229
About this study
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.
- Conditions
- Antibiotic Therapy, Prostate Biopsy
- Being tested
- rPCR results, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rPCR resultsOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Men scheduled for prostate biopsy randomized to Control | Other | Not described Receives: Other: Control group |
| Men scheduled for a prostate biopsy randomized to Intervention | Experimental | Not described Receives: Other: rPCR results |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of prostate biopsy
Secondary outcomes (2)
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).
Measured: Day of prostate biopsy
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Jan 2017
- Primary completion24 Aug 2018
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic TherapyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Liss, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040050
- Sponsor's protocol ID
- 16-386
- Status last verified
- Feb 2020
- First submitted
- 27 Jan 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy
- ClinicalTrials.gov ID
- NCT03040050
- Acronym / sponsor ID
- 16-386
- Conditions
- Antibiotic Therapy, Prostate Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men scheduled for prostate biopsy randomized to Control | Other | Other: Control group |
| Men scheduled for a prostate biopsy randomized to Intervention | Experimental | Other: rPCR results |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rPCR resultsInterventional 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. | Other | Men scheduled for a prostate biopsy randomized to Intervention |
| Control groupControl 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. | Other | Men scheduled for prostate biopsy randomized to Control |
Primary outcome
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.
2 secondary outcomes
Determine if rapid qPCR test results in longer patient wait times.
Time frame: Day of prostate biopsy
Determine if rPCR results and standard rectal culture results are the same.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Liss, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rPCR results in people with Antibiotic Therapy and Prostate Biopsy, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy. (time frame: Day of prostate biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.