Antibiotic Irrigation for Kidney Stones

Overseen By Ankur Choksi, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Intravenous gentamicin

Disqualifiers: Low GFR, Hearing loss, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

Trial Summary

What is the purpose of this trial?

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.

Research Team

Piruz Motamedinia, M.D.

Principal Investigator

Yale School of Medicine, Department of Urology

Eligibility Criteria

This trial is for adults needing surgery for kidney stones who can consent and follow the study plan. They must have had a positive urine culture treated with antibiotics, use effective contraception, and be at higher risk of post-surgery infection due to past UTIs or complications. Excluded are those with poor kidney function, pregnant or breastfeeding women, allergies to gentamicin, recent IV gentamicin use, or certain ear-related health issues.

Inclusion Criteria

I need surgery for kidney stones as per American Urological Association guidelines.

I am willing and able to follow all study rules and attend all appointments.

Provision of signed and dated informed consent form

Exclusion Criteria

I will be given gentamicin through an IV as a preventive measure during surgery.

Known allergic reactions to components of gentamicin

My kidney function is reduced.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopic surgery with either gentamicin-based or NaCl irrigation fluid

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-operative infections and other complications

4 weeks

1 visit (in-person), additional follow-up via phone

Treatment Details

Interventions

• Gentamicin

Trial Overview The study tests if using gentamicin in the irrigation fluid during ureteroscopy can lower post-operative infections compared to a placebo. Participants will undergo standard procedures like cystoscopy and possible laser lithotripsy while being monitored for urinary tract infections (UTIs).

Participant Groups

Group I: Gentamicin-Based Irrigation Experimental Treatment 1 Intervention

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

Group II: 3 L NaCl Irrigation Placebo Group 1 Intervention

This group will receive the typical NaCl irrigation used during ureteroscopy

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+