Antibiotic Selection Using Next Generation Sequencing vs Urine Culture

Not Applicable

Completed

Interventions: Other: NGS + Antibiotic Recommendation
Procedure: Standard of Care treatment

Brief 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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Intervention Group (NGS + Antibiotic Recommendation)	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.
Control Group	Standard of Care treatment	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Infection Post Surgery	One to two weeks after surgery (approximately 100 days from baseline)	Number of participants that develop post surgical infection

Secondary Outcome Measures

Name	Time	Method
Number of Participants for Whom Additional Antibiotics Were Selected	Within 30 days of urine culture and date of surgery (approximately 100 days from baseline)	The number of participants who required their antibiotic treatment to be augmented (additional antibiotic given) or escalated (broader-spectrum antibiotic chosen).

Locations (3): Audie Murphy VA Hospital
🇺🇸
San Antonio, Texas, United States
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
🇺🇸
San Antonio, Texas, United States
University Health System
🇺🇸
San Antonio, Texas, United States