Clinical trial NCT06149455: Preoperative Prophylactic Antibiotic Duration in Moderate to High Risk Ureteroscopy
Official title: A Randomized Controlled Trial of Preoperative Prophylactic Antibiotics for Ureteroscopy in Moderate to High Infectious Risk Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infections, Urinary Tract
Nephrolithiasis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: infectious complication rate
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Non-infectious complications including readmission
timeFrame: 30 days after surgery
measure: Adverse reaction to antibiotic regimen
timeFrame: 2-7 days prior to surgery (depending on which arm the patient was randomized to)
measure: Identification of secondary markers of post-operative sepsis
timeFrame: Obtained during the peri-operative period
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Chi, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: