Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis

NCT06007352 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: 2000035721000
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections; Sepsis

Keywords

UTI; Gentamicin; Ureteroscopy

Outcome Measures

Primary Outcomes (1)

• Symptomatic urinary tract infection

  Development of a symptomatic urinary tract infection after surgery

  Within 30 days of surgery

Secondary Outcomes (3)

• Urosepsis

  Within 30 days of surgery

• Re-admission to hospital

  Within 30 days of surgery

• Patient self-reported symptoms

  within 30 days of surgery

Study Arms (2)

Gentamicin-Based Irrigation

EXPERIMENTAL

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

Drug: Gentamicin

3 L NaCl Irrigation

PLACEBO COMPARATOR

This group will receive the typical NaCl irrigation used during ureteroscopy

Other: Placebo

Interventions

Gentamicin DRUG

Participants will be given 120 mg of gentamicin infused in 3 L NaCl used in irrigation for ureteroscopy

Gentamicin-Based Irrigation

Placebo OTHER

3 L of NaCl irrigation typically used for ureteroscopy surgery

3 L NaCl Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Health

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Sepsis

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Piruz Motamedinia, M.D.

  Yale School of Medicine, Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: phase II, parallel randomized control trial with 1:1 allocation

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)