← Back to Search

Gentamicin-Based Irrigation for Sepsis

Phase 2

Waitlist Available

Led By Piruz Motamedinia, M.D.

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days of surgery

Awards & highlights

Study Summary

This trial tests if a gentamicin-based fluid can reduce infections after surgery using ureteroscopy.

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

Gentamicin may cause side effects such as allergic reactions in some people. It's also associated with potential risks like kidney damage (nephrotoxicity), hearing loss (ototoxicity), and dizziness but these are closely monitored during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Symptomatic urinary tract infection

Secondary outcome measures

Patient self-reported symptoms

Re-admission to hospital

Urosepsis

Side effects data

From 2013 Phase 4 trial • 614 Patients • NCT00926796

40%

Nausea

22%

Diarrhea

14%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Regimen B: Gemifloxacin Plus Azithromycin

Regimen A: Gentamicin Plus Azithromycin

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Gentamicin-Based IrrigationExperimental Treatment1 Intervention

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

Group II: 3 L NaCl IrrigationPlacebo Group1 Intervention

This group will receive the typical NaCl irrigation used during ureteroscopy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gentamicin

2015

Completed Phase 4

~1110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,256 Total Patients Enrolled

4 Trials studying Sepsis

144 Patients Enrolled for Sepsis

Piruz Motamedinia, M.D.Principal InvestigatorYale School of Medicine, Department of Urology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Gentamicin-Based Irrigation as an acceptable treatment?

"The safety of Gentamicin-Based Irrigation was appraised as a 2 on the scale from 1 to 3, as clinical data has been collected for its safety but not yet efficacy."

Answered by AI

Are there still open vacancies for participants in this medical trial?

"Clinicaltrials.gov showcases that this research project, which was launched on September 1st 2023 and last edited August 17th 2023 has stopped recruiting patients. Nevertheless, there are currently 288 other clinical trials enrolling participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis

2024. "Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06007352.

All > Uti > Sepsis