NCT04404855

Antibiotic Selection Using Next Generation Sequencing vs Urine Culture

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Stone
• Renal Stone
• Infection, Bacterial

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-18
• Primary completion: 2022-01-31
• Completion: 2022-08-31
• First posted: 2020-05-28
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

3 sites across 1 country: United States