Preoperative Prophylactic Antibiotic Duration in Moderate to High Risk Ureteroscopy

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Nephrolithiasis; Infections, Urinary Tract
• Intervention / Treatment: Other: Duration of antibiotics

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Chi, MD, MBA; Phone Number: 415-353-2200; Email: tom.chi@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
      • Contact: Victoria Hogue, M.A.; Email: Victoria.Hogue@ucsf.edu
      • Contact: Thomas Chi, M.D.; Phone Number: 415-353-2480; Email: tom.chi@ucsf.edu
      • Sub-Investigator: Wilson Sui, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short duration of preoperative antibiotics (2 days)	Other: Duration of antibiotics; Patients will be randomized to a short (2 days) or long (7 days) of pre-operative antibiotics, the choice of agent will be dependent upon bacterial sensitivities if available which is standard of care.
Active Comparator: Long duration of preoperative antibiotics (7 days)	Other: Duration of antibiotics; Patients will be randomized to a short (2 days) or long (7 days) of pre-operative antibiotics, the choice of agent will be dependent upon bacterial sensitivities if available which is standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infectious complication rate	any occurrence of urinary tract infection, pyelonephritis, systemic inflammatory response syndrome or sepsis	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-infectious complications including readmission	Any other complications after the surgical procedure such as pain, readmission, urinary retention, etc	30 days after surgery
Adverse reaction to antibiotic regimen	Any adverse reaction to antibiotic regimen	2-7 days prior to surgery (depending on which arm the patient was randomized to)
Identification of secondary markers of post-operative sepsis	Markers of infection will be drawn preoperatively including erythrocyte sedimentation rate, c-reactive protein test, intra-operative renal pelvis pressure	Obtained during the peri-operative period

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Thomas Chi, MD, MBA, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Tract Infections; Kidney Calculi; Nephrolithiasis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 22-37824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We have no plans to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No