Antibiotic Selection Using Next Generation Sequencing vs Urine Culture (ACCESS)
Primary Purpose
Kidney Stone, Renal Stone, Infection, Bacterial
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NGS + Antibiotic Recommendation
Standard of Care treatment
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Stone
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
Sites / Locations
- Audie Murphy VA HospitalRecruiting
- The University of Texas Health Science Center at San Antonio, Medical Arts and Research CenterRecruiting
- University Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Intervention Group (NGS + Antibiotic Recommendation)
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Incidence of infection post surgery
Number of participants that develop post surgical infection
Secondary Outcome Measures
Number of antibiotics selected for participants
The number of antibiotics or the number of classes of antibiotics prescribed
Full Information
NCT ID
NCT04404855
First Posted
May 13, 2020
Last Updated
June 18, 2021
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
MicroGen DX
1. Study Identification
Unique Protocol Identification Number
NCT04404855
Brief Title
Antibiotic Selection Using Next Generation Sequencing vs Urine Culture
Acronym
ACCESS
Official Title
Antibiotic Selection Using Next Generation Sequencing (NGS) Versus Urine Culture for Stewardship Prior to Surgery Using an Interprofessional Model
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
MicroGen DX
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Renal Stone, Infection, Bacterial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group (NGS + Antibiotic Recommendation)
Arm Type
Other
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
NGS + Antibiotic Recommendation
Intervention Description
NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
Intervention Type
Procedure
Intervention Name(s)
Standard of Care treatment
Intervention Description
Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
Primary Outcome Measure Information:
Title
Incidence of infection post surgery
Description
Number of participants that develop post surgical infection
Time Frame
One to two weeks after surgery
Secondary Outcome Measure Information:
Title
Number of antibiotics selected for participants
Description
The number of antibiotics or the number of classes of antibiotics prescribed
Time Frame
Within 30 days of urine culture and date of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Liss, MD
Phone
210-567-5676
Email
liss@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Hudson, BS
Phone
210-450-8688
Email
hudsonr1@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Liss, MD
Organizational Affiliation
University of Texas Health at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Audie Murphy VA Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Liss, MD
Phone
210-567-5640
Email
liss@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Molly Doris
Phone
210-567-1172
Email
doris@uthscsa.edu
Facility Name
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Liss, MD
Phone
210-567-5676
Email
Liss@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Molly Doris, BS
Phone
210-567-1172
Email
doris@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Michael Liss, MD
Facility Name
University Health System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Liss, MD
Phone
210-567-5640
Email
liss@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Molly Doris
Phone
210-567-1172
Email
doris@uthscsa.edu
12. IPD Sharing Statement
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Antibiotic Selection Using Next Generation Sequencing vs Urine Culture
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