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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
240
NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
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
Incidence of Infection Post Surgery
Number of participants that develop post surgical infection
Time frame: One to two weeks after surgery (approximately 100 days from baseline)
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).
Time frame: Within 30 days of urine culture and date of surgery (approximately 100 days from baseline)
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