CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 86 enrolled
Drug / intervention
nitrofurantoin monohydrate/macrocrystalline capsules +4 moredrug
Likely dose
nitrofurantoin monohydrate/macrocrystalline capsules 100 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02384200
NCT02384200Phase 4Completed
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The EDGE Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy: Part 1

University of California, San Diego·interventional·Posted Mar 10, 2015·Updated Aug 22, 2019

In Brief

A Phase 4 clinical trial evaluating nitrofurantoin monohydrate/macrocrystalline capsules, ampicillin, and 3 other interventions for Nephrolithiasis and Urinary Tract Infections. Completed, enrolled 86 participants across 8 sites in 2 countries.

Detailed Summary

When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy \[PCNL\]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNephrolithiasis, Urinary Tract Infections
CountriesCanada, United States
CollaboratorsMayo Clinic, University of British Columbia, The Cleveland Clinic, Duke University, Ohio State University, Dartmouth-Hitchcock Medical Center, Vanderbilt University, New York University

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 10, 2015
Enrollment StartMar 1, 2015
Primary CompletionFeb 1, 2017
Study CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.3 years ago

Interventions

nitrofurantoin monohydrate/macrocrystalline capsulesdrug

1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily

ampicillindrug

IV (2 g)

gentamicindrug

IV (5 mg/kg)

vancomycindrug

IV (1 g)

ceftriaxonedrug

IV (2 g)