Kidney StoneACCESSNCT04404855
Antibiotic Selection Using Next Generation Sequencing vs Urine Culture
A study testing NGS + Antibiotic Recommendation in people with Kidney Stone and Renal Stone, run by The University of Texas Health Science Center at San Antonio at 3 sites in United States.
Trial summary
This is a randomized controlled clinical study evaluating the use of next-generation sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Renal Stone, Infection, Bacterial
- What is being tested?
- NGS + Antibiotic Recommendation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Dec 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planning to undergo kidney or bladder stone removal surgery using endoscopy including ureteroscopy and percutaneous nephrolithotomy or any other transurethral procedure
- Age 18 or older
- Able to give informed consent
Who cannot join
- Unwilling or unable to provide informed consent
- Age < 18
- Does not meet inclusion criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Audie Murphy VA Hospital
San Antonio, Texas, 78229
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
San Antonio, Texas, 78229
University Health System
San Antonio, Texas, 78229
About this study
Official title: Randomized Clinical Trial Using Next Generation Microbial Sequencing to Direct Antibiotic Selection Before Kidney Stone Lithotripsy Using an Interprofessional Model
This is a randomized controlled clinical study evaluating the use of next-generation sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy.
Read the detailed description
NGS will be performed on voided urine collected as routine care approximately 30 days prior to surgery. Results will be presented to Infectious Disease pharmacist within 48-72 hours to help select the most appropriate antibiotics, and independently as part of routine care, surgeons will choose the antibiotic that they would use in each case, while the Infectious Disease pharmacists would select their optimum choice. Approximately 220 subjects will be randomly assigned in a 1:1 ratio to receive either NGS antibiotic recommendation or standard of care (SOC) prophylaxis prescribed treatment. Subjects assigned to standard of care will have urine cultures sent for analysis, and the physician will choose antibiotics based on results as per usual practice. Subjects assigned to the NGS group, in addition to routine urine culture results, will have NGS urine culture results sent to an investigational drrug (ID) pharmacist, and recommendations will be shared with the physician to determine the antibiotic selection. The physician will ultimately decide the appropriate antibiotics to prescribe. Approximately 7-14 days after surgery, the research staff will conduct a telephone call to ask about any post-operative infections, complications, and any additional antibiotics that were prescribed.
- Conditions
- Kidney Stone, Renal Stone, Infection, Bacterial
- Being tested
- NGS + Antibiotic Recommendation, Standard of Care treatment
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS + Antibiotic RecommendationOther
NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
Standard of Care treatmentProcedure or surgery
Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (NGS + Antibiotic Recommendation) | Other | Next Generation Sequencing results along with Infectious Disease Pharmacist will be shared with clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider. Receives: Other: NGS + Antibiotic Recommendation |
| Control Group | Other | NGS results will not be shared with the clinical provider at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider. Receives: Procedure: Standard of Care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Infection Post Surgery
Number of participants that develop post surgical infection
Measured: One to two weeks after surgery (approximately 100 days from baseline)
Secondary outcomes (1)
Number of Participants for Whom Additional Antibiotics Were Selected
The number of participants who required their antibiotic treatment to be augmented (additional antibiotic given) or escalated (broader-spectrum antibiotic chosen).
Measured: Within 30 days of urine culture and date of surgery (approximately 100 days from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start18 Dec 2019
- Primary completion31 Jan 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Parallel
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Microgen LLC
- Responsible party
- Sponsor
- Investigators
- Michael Liss, MD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404855
- Sponsor's protocol ID
- HSC20190678H
- Acronym
- ACCESS
- Status last verified
- Mar 2024
- First submitted
- 13 May 2020
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data be shared, in addition to the individual participant data set and data dictionaries for the IPD itself.
Publications
Liss MA, Reveles KR, Tipton CD, Gelfond J, Tseng T. Comparative Effectiveness Randomized Clinical Trial Using Next-generation Microbial Sequencing to Direct Prophylactic Antibiotic Choice Before Urologic Stone Lithotripsy Using an Interprofessional Model. Eur Urol Open Sci. 2023 Sep 28;57:74-83. doi: 10.1016/j.euros.2023.09.008. eCollection 2023 Nov.
PubMed 38020524
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Using Next Generation Microbial Sequencing to Direct Antibiotic Selection Before Kidney Stone Lithotripsy Using an Interprofessional Model
- ClinicalTrials.gov ID
- NCT04404855
- Acronym / sponsor ID
- ACCESS / HSC20190678H
- Conditions
- Kidney Stone, Renal Stone, Infection, Bacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Microgen LLC
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled clinical study evaluating the use of next-generation sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy.
Detailed description
NGS will be performed on voided urine collected as routine care approximately 30 days prior to surgery. Results will be presented to Infectious Disease pharmacist within 48-72 hours to help select the most appropriate antibiotics, and independently as part of routine care, surgeons will choose the antibiotic that they would use in each case, while the Infectious Disease pharmacists would select their optimum choice. Approximately 220 subjects will be randomly assigned in a 1:1 ratio to receive either NGS antibiotic recommendation or standard of care (SOC) prophylaxis prescribed treatment. Subjects assigned to standard of care will have urine cultures sent for analysis, and the physician will choose antibiotics based on results as per usual practice. Subjects assigned to the NGS group, in addition to routine urine culture results, will have NGS urine culture results sent to an investigational drrug (ID) pharmacist, and recommendations will be shared with the physician to determine the antibiotic selection. The physician will ultimately decide the appropriate antibiotics to prescribe. Approximately 7-14 days after surgery, the research staff will conduct a telephone call to ask about any post-operative infections, complications, and any additional antibiotics that were prescribed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (NGS + Antibiotic Recommendation) | Other | Other: NGS + Antibiotic RecommendationNext Generation Sequencing results along with Infectious Disease Pharmacist will be shared with clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider. |
| Control Group | Other | Procedure: Standard of Care treatmentNGS results will not be shared with the clinical provider at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients planning to undergo kidney or bladder stone removal surgery using endoscopy including ureteroscopy and percutaneous nephrolithotomy or any other transurethral procedure
- Age 18 or older
- Able to give informed consent
Key exclusion criteria (3 listed)
- Unwilling or unable to provide informed consent
- Age < 18
- Does not meet inclusion criteria
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 |
|---|---|---|
| NGS + Antibiotic RecommendationNGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist | Other | Intervention Group (NGS + Antibiotic Recommendation) |
| Standard of Care treatmentSubjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care. | Procedure or surgery | Control Group |
Primary outcome
Incidence of Infection Post Surgery
Time frame: One to two weeks after surgery (approximately 100 days from baseline)
Number of participants that develop post surgical infection
1 secondary outcome
Number of Participants for Whom Additional Antibiotics Were Selected
Time frame: Within 30 days of urine culture and date of surgery (approximately 100 days from baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38020524Liss MA, Reveles KR, Tipton CD, Gelfond J, Tseng T. Comparative Effectiveness Randomized Clinical Trial Using Next-generation Microbial Sequencing to Direct Prophylactic Antibiotic Choice Before Urologic Stone Lithotripsy Using an Interprofessional Model. Eur Urol Open Sci. 2023 Sep 28;57:74-83. doi: 10.1016/j.euros.2023.09.008. eCollection 2023 Nov.
- Comparative Effectiveness Randomized Clinical Trial Using Next-generation Microbial Sequencing to Direct Prophylactic Antibiotic Choice Before Urologic Stone Lithotripsy Using an Interprofessional ModelLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified data be shared, in addition to the individual participant data set and data dictionaries for the IPD itself.
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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
University of Texas Health at San Antonio
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NGS + Antibiotic Recommendation in people with Kidney Stone and Renal Stone, run by The University of Texas Health Science Center at San Antonio at 3 sites 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 3 inclusion and 3 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Infection Post Surgery (time frame: One to two weeks after surgery (approximately 100 days from baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04404855, which also lists 1 linked publication.
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 12 Mar 2024.