Antibiotic Selection Using Next Generation Sequencing vs Urine Culture

Kidney Stone Clinical Trial

— ACCESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404855
• Other study ID #: HSC20190678H
• Status: Completed
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Calculi
• Infection, Bacterial
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Renal Stone

Intervention

Other:
• NGS + Antibiotic Recommendation
NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist

Procedure:
• Standard of Care treatment
Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.

Locations

Country	Name	City	State
United States	Audie Murphy VA Hospital	San Antonio	Texas
United States	The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center	San Antonio	Texas
United States	University Health System	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	MicroGen DX

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)

External Links

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