Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Urinary Tract Infections, Sepsis

In brief

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.

Key facts

Study ID

NCT06007352

Run by

Yale University

People needed

0

Starts

2024-10-01

Expected to finish

2025-10-01

Last updated by the study team

2025-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale New Haven Health — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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