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Clinical Trials/NCT04404855
NCT04404855CompletedNot Applicable

Randomized Clinical Trial Using Next Generation Microbial Sequencing to Direct Antibiotic Selection Before Kidney Stone Lithotripsy Using an Interprofessional Model

The University of Texas Health Science Center at San Antonio6 sites in 1 country240 target enrollmentStarted: December 18, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
240
Locations
6
Primary Endpoint
Incidence of Infection Post Surgery

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incidence of Infection Post Surgery

Time Frame: One to two weeks after surgery (approximately 100 days from baseline)

Number of participants that develop post surgical infection

Secondary Outcomes

  • Number of Participants for Whom Additional Antibiotics Were Selected(Within 30 days of urine culture and date of surgery (approximately 100 days from baseline))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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