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Clinical Trials/NCT04404855
NCT04404855
Completed
Not 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 Antonio3 sites in 1 country240 target enrollmentDecember 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Stone
Sponsor
The University of Texas Health Science Center at San Antonio
Enrollment
240
Locations
3
Primary Endpoint
Incidence of Infection Post Surgery
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 18, 2019
End Date
August 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

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))

Study Sites (3)

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