Antibiotic Selection Using Next Generation Sequencing vs Urine Culture (ACCESS)

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

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

Study Overview

• Status: Completed
• Conditions: Infection, Bacterial; Kidney Stone; Renal Stone
• Intervention / Treatment: Other: NGS + Antibiotic Recommendation; Procedure: Standard of Care treatment

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University Health System
    • San Antonio, Texas, United States, 78229
      • Audie Murphy VA Hospital
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: NGS + Antibiotic Recommendation; NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
Other: 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.	Procedure: Standard of Care treatment; Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Infection Post Surgery	Number of participants that develop post surgical infection	One to two weeks after surgery (approximately 100 days from baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants for Whom Additional Antibiotics Were Selected	The number of participants who required their antibiotic treatment to be augmented (additional antibiotic given) or escalated (broader-spectrum antibiotic chosen).	Within 30 days of urine culture and date of surgery (approximately 100 days from baseline)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: MicroGen DX
• Investigators: Principal Investigator: Michael Liss, MD, University of Texas Health at San Antonio

Publications and helpful links

General Publications

• 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.

Helpful Links

• Comparative Effectiveness Randomized Clinical Trial Using Next-generation Microbial Sequencing to Direct Prophylactic Antibiotic Choice Before Urologic Stone Lithotripsy Using an Interprofessional Model

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Kidney Diseases; Urologic Diseases; Bacterial Infections and Mycoses; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Kidney Calculi; Nephrolithiasis; Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: HSC20190678H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data be shared, in addition to the individual participant data set and data dictionaries for the IPD itself.
• IPD Sharing Time Frame: At the time of publication in a peer review journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No