MedTrace Logo

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

NCT02829060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

  • Nephrolithiasis
  • Urinary Tract Infection (UTI)
  • Sepsis

Interventions

DRUG

Nitrofurantoin 100 MG, 7d

7 day course, 100 mg twice daily, PO

DRUG

Gentamicin, 5mg/kg

Peri-operative dose: 5 mg/kg of ideal body weight, IV

DRUG

Ampicillin 2g

Peri-operative dose: 2 grams, IV

DRUG

Nitrofurantoin 100 mg, 48 hrs

48 hour course, 100 mg twice daily, PO

DRUG

Gentamicin, 80 mg, 7d

7 day course, 80 mg daily, IM or IV

DRUG

Gentamicin, 80 mg, 48hr

48 hour course, 80 mg daily, IM or IV

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2025-01-31
Completion
2025-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02829060 on ClinicalTrials.gov