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| Name | Class |
|---|---|
| Microgen LLC | INDUSTRY |
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This is a randomized controlled clinical study evaluating the use of next-generation sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGS + Antibiotic Recommendation | Other | NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Infection Post Surgery | Number of participants that develop post surgical infection | One to two weeks after surgery (approximately 100 days from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Within 30 days of urine culture and date of surgery (approximately 100 days from baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Liss, MD | University of Texas Health at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Audie Murphy VA Hospital | San Antonio | Texas | 78229 | United States | ||
| The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38020524 | Result | 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. |
| Label | URL |
|---|---|
| Comparative Effectiveness Randomized Clinical Trial Using Next-generation Microbial Sequencing to Direct Prophylactic Antibiotic Choice Before Urologic Stone Lithotripsy Using an Interprofessional Model | View source |
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Deidentified data be shared, in addition to the individual participant data set and data dictionaries for the IPD itself.
At the time of publication in a peer review journal
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group (NGS + Antibiotic Recommendation) | 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. NGS + Antibiotic Recommendation: NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist |
| FG001 | Control Group | 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. Standard of Care treatment: Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
50 subjects from the intervention group were included in the analysis population and 86 in the control group. Other subjects were screen failures or non-compliant with study procedures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group (NGS + Antibiotic Recommendation) | 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. NGS + Antibiotic Recommendation: NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Infection Post Surgery | Number of participants that develop post surgical infection | Patients planning to undergo kidney or bladder stone removal surgery using endoscopy including ureteroscopy and percutaneous nephrolithotomy | Posted | Number | participants | One to two weeks after surgery (approximately 100 days from baseline) |
|
Adverse events are collected from Baseline (day 1) up to 90 days from enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group (NGS + Antibiotic Recommendation) | 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. NGS + Antibiotic Recommendation: NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment | Hypoglycemia was attributed to a 3 gram dose of cefazolin, the subject presented with a yeast infection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Liss, MD | UT Health San Antonio | 210-567-5676 | liss@uthscsa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2021 | Aug 29, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Parallel
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| Standard of Care treatment | Procedure | Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care. |
|
| San Antonio |
| Texas |
| 78229 |
| United States |
| University Health System | San Antonio | Texas | 78229 | United States |
| BG001 | Control Group | 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. Standard of Care treatment: Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes diagnosis | Count of Participants | Participants |
|
| Ureteral stent in place | Count of Participants | Participants |
|
| Surgery type | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Median | Full Range | Kg/m^2 |
|
| OG001 | Control Group | 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. Standard of Care treatment: Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care. |
|
|
| Secondary | 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). | Patients planning to undergo kidney or bladder stone removal surgery using endoscopy including ureteroscopy and percutaneous nephrolithotomy | Posted | Count of Participants | Participants | Within 30 days of urine culture and date of surgery (approximately 100 days from baseline) |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Control Group | 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. Standard of Care treatment: Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care. | 0 | 86 | 0 | 86 | 1 | 86 |
|
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| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |