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