Nephrolithiasis Clinical Trial
Official title:
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
Status | Not yet recruiting |
Enrollment | 72 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | infectious complication rate | any occurrence of urinary tract infection, pyelonephritis, systemic inflammatory response syndrome or sepsis | 30 days after surgery | |
Secondary | Non-infectious complications including readmission | Any other complications after the surgical procedure such as pain, readmission, urinary retention, etc | 30 days after surgery | |
Secondary | 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) | |
Secondary | 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 |
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