NCT04404855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

2.1 years

First QC Date

May 13, 2020

Results QC Date

September 1, 2022

Last Update Submit

March 11, 2024

Conditions

Kidney StoneRenal StoneInfection, Bacterial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Participants for Whom Additional Antibiotics Were Selected

    Within 30 days of urine culture and date of surgery (approximately 100 days from baseline)

Study Arms (2)

Intervention Group (NGS + Antibiotic Recommendation)

OTHER

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

Control Group

OTHER

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

Interventions

NGS + Antibiotic RecommendationOTHER

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

Intervention Group (NGS + Antibiotic Recommendation)
Standard of Care treatmentPROCEDURE

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

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unwilling or unable to provide informed consent
  • Age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Audie Murphy VA Hospital

San Antonio, Texas, 78229, United States

Location

The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center

San Antonio, Texas, 78229, United States

Location

University Health System

San Antonio, Texas, 78229, United States

Location

Related 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. Eur Urol Open Sci. 2023 Sep 28;57:74-83. doi: 10.1016/j.euros.2023.09.008. eCollection 2023 Nov.

    PMID: 38020524RESULT

Related Links

MeSH Terms

Conditions

Kidney CalculiNephrolithiasisBacterial Infections

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Michael Liss, MD
Organization
UT Health San Antonio
liss@uthscsa.edu
210-567-5676

Study Officials

  • Michael Liss, MD

    University of Texas Health at San Antonio

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 28, 2020

Study Start

December 18, 2019

Primary Completion

January 31, 2022

Study Completion

August 31, 2022

Last Updated

March 12, 2024

Results First Posted

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Deidentified data be shared, in addition to the individual participant data set and data dictionaries for the IPD itself.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
At the time of publication in a peer review journal

Locations

US(3)