Status:
WITHDRAWN
Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis
Lead Sponsor:
Yale University
Conditions:
Urinary Tract Infections
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06007352
Start Date
October 1 2024
End Date
October 1 2025
Last Update
January 16 2025
Active Locations (1)
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1
Yale New Haven Health
New Haven, Connecticut, United States, 06510