Antibiotic Selection Using Next Generation Sequencing vs Urine Culture

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Antibiotic Selection Using Next Generation Sequencing (NGS) Versus Urine Culture for Stewardship Prior to Surgery Using an Interprofessional Model

Conditions
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Kidney Stone, Renal Stone, Infection, Bacterial

Intervention / Treatment
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* Other: NGS + Antibiotic Recommendation
* Procedure: Standard of Care treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unwilling or unable to provide informed consent Age < 18 Does not meet inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention Group (NGS + Antibiotic Recommendation)<br>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. | Other: NGS + Antibiotic Recommendation<br>* NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist<br>|
| Other: Control Group<br>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. | Procedure: Standard of Care treatment<br>* Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infection post surgery | Number of participants that develop post surgical infection | One to two weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of antibiotics selected for participants | The number of antibiotics or the number of classes of antibiotics prescribed | Within 30 days of urine culture and date of surgery |