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Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis

Primary Purpose

Urinary Tract Infections, Sepsis

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gentamicin
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring UTI, Gentamicin, Ureteroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Diagnosed with urolithiasis (obstructing ureteral stone, large non-obstructing renal stones) warranting surgical intervention in line with American Urological Association guidelines for urolithiasis At a higher risk for infectious complications following ureteroscopy based on a history of atleast one of the below: 3 more urinary tract infections over 12 month period not on suppressive antibiotic therapy Prior infectious complication following ureteroscopy Placement of ureteral stent in the setting of obstructing ureteral stone with concern for superimposed urinary tract infection Positive pre-operative urine culture treated with culture-appropriate antimicrobial therapy Planned for cystoscopy, ureteroscopy with possible laser lithotripsy, and ureteral stent placement For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 8 weeks after the end of gentamicin administration. Female patients of reproductive potential will have pregnancy screen prior to surgery per standard operating room protocol. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner Exclusion Criteria: Estimated Glomerular Filtration Rate less than 60 mL/min History of sensorineural hearing loss, vertigo, idiopathic dizziness Active pregnancy or currently lactating Known allergic reactions to components of gentamicin Administration of intravenous gentamicin as part of surgical antibiotic prophylaxis

Sites / Locations

  • Yale New Haven Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gentamicin-Based Irrigation

3 L NaCl Irrigation

Arm Description

This group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy

This group will receive the typical NaCl irrigation used during ureteroscopy

Outcomes

Primary Outcome Measures

Symptomatic urinary tract infection
Development of a symptomatic urinary tract infection after surgery

Secondary Outcome Measures

Urosepsis
Development of urosepsis after URS based on SIRS criteria
Re-admission to hospital
Re-admission to hospital after surgery for any reason
Patient self-reported symptoms
Self-reported symptoms after the operation of the following: new hearing loss, vertigo and dizziness

Full Information

First Posted
August 17, 2023
Last Updated
August 17, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT06007352
Brief Title
Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis
Official Title
Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The purpose of the study is to investigate whether the use of gentamicin-based irrigation fluid during ureteroscopy decreases the risk of UTIs and other post-operative infections after surgery.
Detailed Description
The primary objective of this study is to determine whether the utilization of gentamicin-based irrigation fluid during ureteroscopy decreases the rate of 30-day post-operative symptomatic urinary tract infections in patients at higher risk of urinary tract infection undergoing stone surgery for urolithiasis. The secondary objectives of this study are to determine whether the utilization of gentamicin-based irrigation fluid during ureteroscopy affects the 30-day post-operative rates of patient-initiated telephone calls, readmission rates, urosepsis rates based on SIRS criteria, and overall post-operative oral/intravenous antibiotic administration. In this prospective study, 120 mg of gentamicin prepared in 3 liters of normal saline will be used as irrigation during ureteroscopic surgery for urolithiasis. At this concentration, 40 μg/mL, the MBC would be achieved for pathogenic urogenital bacteria. Due to the concerns of nephrotoxicity and ototoxicity at higher doses of gentamicin, in the unlikely event of complete pyelo-venous backflow, the intravenous circulation of 120 mg of gentamicin would be less than the surgical prophylaxis intravenous dosing for patients weighing more than 60 kg. For the single intravenous dose for surgical prophylaxis, post-operative monitoring of renal function, and gentamicin peak and trough levels are not routinely obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Sepsis
Keywords
UTI, Gentamicin, Ureteroscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
phase II, parallel randomized control trial with 1:1 allocation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
412 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gentamicin-Based Irrigation
Arm Type
Experimental
Arm Description
This group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy
Arm Title
3 L NaCl Irrigation
Arm Type
Placebo Comparator
Arm Description
This group will receive the typical NaCl irrigation used during ureteroscopy
Intervention Type
Drug
Intervention Name(s)
Gentamicin
Intervention Description
Participants will be given 120 mg of gentamicin infused in 3 L NaCl used in irrigation for ureteroscopy
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
3 L of NaCl irrigation typically used for ureteroscopy surgery
Primary Outcome Measure Information:
Title
Symptomatic urinary tract infection
Description
Development of a symptomatic urinary tract infection after surgery
Time Frame
Within 30 days of surgery
Secondary Outcome Measure Information:
Title
Urosepsis
Description
Development of urosepsis after URS based on SIRS criteria
Time Frame
Within 30 days of surgery
Title
Re-admission to hospital
Description
Re-admission to hospital after surgery for any reason
Time Frame
Within 30 days of surgery
Title
Patient self-reported symptoms
Description
Self-reported symptoms after the operation of the following: new hearing loss, vertigo and dizziness
Time Frame
within 30 days of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Diagnosed with urolithiasis (obstructing ureteral stone, large non-obstructing renal stones) warranting surgical intervention in line with American Urological Association guidelines for urolithiasis At a higher risk for infectious complications following ureteroscopy based on a history of atleast one of the below: 3 more urinary tract infections over 12 month period not on suppressive antibiotic therapy Prior infectious complication following ureteroscopy Placement of ureteral stent in the setting of obstructing ureteral stone with concern for superimposed urinary tract infection Positive pre-operative urine culture treated with culture-appropriate antimicrobial therapy Planned for cystoscopy, ureteroscopy with possible laser lithotripsy, and ureteral stent placement For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 8 weeks after the end of gentamicin administration. Female patients of reproductive potential will have pregnancy screen prior to surgery per standard operating room protocol. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner Exclusion Criteria: Estimated Glomerular Filtration Rate less than 60 mL/min History of sensorineural hearing loss, vertigo, idiopathic dizziness Active pregnancy or currently lactating Known allergic reactions to components of gentamicin Administration of intravenous gentamicin as part of surgical antibiotic prophylaxis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piruz Motamedinia, M.D.
Phone
203-785-2815
Email
piruz.motamedinia@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ankur Choksi, M.D.
Email
ankur.choksi@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piruz Motamedinia, M.D.
Organizational Affiliation
Yale School of Medicine, Department of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Health
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piruz Motamedinia, M.D.
Email
piruz.motamedinia@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis

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