Antibiotic Selection Using Next Generation Sequencing vs Urine Culture

  • STATUS
    Recruiting
  • participants needed
    220
  • sponsor
    The University of Texas Health Science Center at San Antonio
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Updated on 19 February 2024
See if I qualify
antibiotics
antibiotic therapy
endoscopy
percutaneous nephrolithotomy
urine culture
stone removal
nephrolithotomy
stone extraction
bladder stone

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.

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.

Details
Condition Bacterial Infection, Nephropathy, Nephropathy, KIDNEY STONE, kidney stones, kidney stones
Age 18years - 100years
Treatment NGS + Antibiotic Recommendation, Standard of Care treatment
Clinical Study IdentifierNCT04404855
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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stone extraction
bladder stone

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