Overview

Endourology Disease Group Excellence (EDGE) Consortium: Antibiotics (Abx) for Percutaneous Nephrolithotomy (PCNL) Part 2

Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
0
Participant gender:
All
Summary
This study will be a multi-institutional randomized clinical trial of a short course of pre-operative antibiotic prophylaxis in addition to perioperative antibiotics prior to undergoing percutaneous nephrolithotomy. The select patient population will be those patients deemed to be at a moderately increased risk of postoperative infectious complications. These higher risk patients are those with indwelling urinary drainage tubes and those with a positive preoperative urine culture.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, San Diego
Treatments:
Ampicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Cefpodoxime
Cefpodoxime proxetil
Cephalexin
Ciprofloxacin
Doxycycline
Gentamicins
Nitrofurantoin
Sulfamethoxazole
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Criteria
Age: >17 years of age

Gender: both men and women included. We anticipated enrolling a study population of
approximately 60% men and 40% women based on a higher incidence of kidney stones among men
in NHANES data.

Ethnic background: all ethnicities will be included in the study population and the
specific ethnic diversity present in the study population will reflect the geographic
distributions of the participating institutions.

Health status: see below for specific inclusion/exclusion criteria.

Inclusion criteria:

- Renal stone of any size for which PCNL is recommended

- Positive preoperative urine culture within 3 months

- Current internalized ureteral stent, nephrostomy tube, nephroureteral stent

Exclusion criteria

- Patients age <18

- Active pregnancy

- Patients receiving antibiotic doses (other than prescribed for the study) within the
seven days preceding surgery