drugset / Trial / NCT02829060

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

NCT02829060

Completed 330 enrolled University of California, San Diego
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2016-01
Primary completion
2025-01
Completion
2025-03

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gentamicin Small molecule 5 mg/kg Intravenous
Comparator Gentamicin Small molecule 80 mg Intravenous
Comparator Nitrofurantoin Unknown 100 mg Oral
Comparator Ampicillin Unknown 2 g Intravenous