Preoperative Prophylactic Antibiotic Duration in Moderate to High Risk Ureteroscopy

NCT ID: NCT06149455

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-01-01

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.

Conditions

Infections, Urinary Tract; Nephrolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short duration of preoperative antibiotics (2 days)

Group Type: EXPERIMENTAL

Duration of antibiotics

Intervention Type: OTHER

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.

Long duration of preoperative antibiotics (7 days)

Group Type: ACTIVE_COMPARATOR

Duration of antibiotics

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Chi, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Central Contacts

Thomas Chi, MD, MBA

Role: CONTACT

Phone: 415-353-2200

Email: tom.chi@ucsf.edu

Facility Contacts

Thomas Chi, M.D.

Role: primary

Victoria Hogue, M.A.

Role: backup

Other Identifiers

22-37824

Identifier Type: -

Identifier Source: org_study_id