Clinical trial NCT04404855: Antibiotic Selection Using Next Generation Sequencing vs Urine Culture
Official title: Randomized Clinical Trial Using Next Generation Microbial Sequencing to Direct Antibiotic Selection Before Kidney Stone Lithotripsy Using an Interprofessional Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Renal Stone
Infection, Bacterial
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Microgen LLC
First posted: 2020-05-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Infection Post Surgery
timeFrame: One to two weeks after surgery (approximately 100 days from baseline)
Secondary outcomes:
measure: Number of Participants for Whom Additional Antibiotics Were Selected
timeFrame: Within 30 days of urine culture and date of surgery (approximately 100 days from baseline)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Audie Murphy VA Hospital
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
state: Texas
city: San Antonio
country: United States
facility: University Health System
state: Texas
Study officials:
affiliation: University of Texas Health at San Antonio
name: Michael Liss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.