Summary

Eligibility
for people ages 18-99 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Thomas Chi, MD, MBA
Headshot of Thomas Chi
Thomas Chi

Description

Summary

The goal of this non-inferiority randomized controlled trial: is to test the hypothesis that the that there is no additional benefit from a longer course (7 days) versus a shorter course (2 days) of pre-operative antibiotics in patients with moderate to high risk of infection undergoing ureteroscopy. The main questions it aims to answer are:

  1. Determine the safety and efficacy of a short course (2 days) as compared to a long course (7 days)
  2. Identify secondary predictors of post-operative infectious complications

Official Title

A Randomized Controlled Trial of Preoperative Prophylactic Antibiotics for Ureteroscopy in Moderate to High Infectious Risk Population

Details

Post-operative infectious complications including urinary tract infection (UTI), systemic inflammatory response syndrome (SIRS), and sepsis are uncommon but potentially devastating complications after ureteroscopy. The clinical guidance from the American Urologic Association (AUA) and the European Association of Urology (EAU) is to provide treatment for symptomatic urinary tract infections however the management for asymptomatic patients with positive cultures or those patients who are otherwise at high risk of urinary tract colonization is unclear. As a result, there is significant practice variation in pre-operative prophylactic antibiotic prescription, even amongst fellowship trained endourologists, with some providers prescribing over ten days of pre-operative antibiotics while others offer none. This is a critical gap in our understanding of pre-operative prophylactic antibiotic utilization in a population of patients not only at higher risk of harboring multi-drug resistant (MDR) organisms but are also more susceptible to deleterious outcomes due to their frailty. Recent randomized trials have demonstrated that short courses of pre-operative antibiotics are no less protective than long courses in patients undergoing percutaneous nephrolithotomy (PCNL) for stone removal. Ureteroscopy is the most commonly performed stone surgery worldwide. Establishing an evidence-based approach for antibiotic prophylaxis in the ureteroscopic surgical patient population will be impactful for a large number of patients. The goal of this study is to implement a well-designed randomized clinical trial to establish the standardized antibiotic protocol necessary to minimize unnecessary antibiotic use which may otherwise lead to adverse reactions and proliferation of multi-drug resistant organisms.

Keywords

Infections, Urinary Tract, Nephrolithiasis, Urinary Tract Infections, Kidney Calculi, Anti-Bacterial Agents, Duration of antibiotics, Short duration of preoperative antibiotics (2 days), Long duration of preoperative antibiotics (7 days)

Eligibility

You can join if…

Open to people ages 18-99

  • age (greater than or equal to 18 years)
  • indwelling ureteral stent in place
  • nephrostomy tube in place
  • indwelling foley catheter, suprapubic catheter or clean intermittent catheterization
  • asymptomatic bacteriuria
  • bowel interposition (such as ileal conduit, neobladder)
  • immunosuppression (such as for transplant recipients, active chemotherapy use)

You CAN'T join if...

  • pregnancy
  • active infection
  • received antibiotics within 7 days preceding surgery that were not prescribed for the study

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Thomas Chi, MD, MBA
    Professor, Urology, School of Medicine. Authored (or co-authored) 142 research publications. Research interests: Nephrolithiasis · Benign Prostatic Hypertrophy (BPH) · Ultrasound · Minimally Invasive Surgery · Laparoscopy

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06149455
Study Type
Interventional
Participants
Expecting 72 study participants
Last Updated