Antibiotic Selection Using Next Generation Sequencing vs Urine Culture

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-18

Study Completion Date

2022-08-31

Brief Summary

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This is a randomized controlled clinical study evaluating the use of next-generation sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy.

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Detailed Description

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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.

Conditions

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Kidney Stone Renal Stone Infection, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Group (NGS + Antibiotic Recommendation)

Next Generation Sequencing results along with Infectious Disease Pharmacist will be shared with clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.

Group Type OTHER

NGS + Antibiotic Recommendation

Intervention Type OTHER

NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist

Control Group

NGS results will not be shared with the clinical provider at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.

Group Type OTHER

Standard of Care treatment

Intervention Type PROCEDURE

Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.

Interventions

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NGS + Antibiotic Recommendation

NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist

Intervention Type OTHER

Standard of Care treatment

Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.

Intervention Type PROCEDURE

Eligibility Criteria

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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