Preoperative Prophylactic Antibiotic Duration in Moderate to High Risk Ureteroscopy

NCT06149455 | Unknown

• 1 other identifier: 22-37824
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Infections, Urinary Tract; Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• infectious complication rate

  any occurrence of urinary tract infection, pyelonephritis, systemic inflammatory response syndrome or sepsis

  30 days after surgery

Secondary Outcomes (3)

• Non-infectious complications including readmission

  30 days after surgery

• 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

  Obtained during the peri-operative period

Study Arms (2)

Short duration of preoperative antibiotics (2 days)

EXPERIMENTAL

Other: Duration of antibiotics

Long duration of preoperative antibiotics (7 days)

ACTIVE COMPARATOR

Other: Duration of antibiotics

Interventions

Duration of antibiotics 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); Short duration of preoperative antibiotics (2 days)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Nephrolithiasis

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urolithiasis

Study Officials

• Thomas Chi, MD, MBA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Chi, MD, MBA

CONTACT

415-353-2200; tom.chi@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 29, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)