A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])

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).

Conditions

• Nephrolithiasis
• Urinary Tract Infections

Interventions

DRUG

nitrofurantoin monohydrate/macrocrystalline capsules

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

DRUG

ampicillin

IV (2 g)

DRUG

gentamicin

IV (5 mg/kg)

DRUG

vancomycin

IV (1 g)

DRUG

ceftriaxone

IV (2 g)

Sponsors & Collaborators

• Mayo Clinic

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Duke University

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• New York University

  collaborator OTHER

• University of California, San Diego

  lead OTHER

Principal Investigators

• Roger L Sur, MD · University of California, San Diego

• Daniel L Miller, MD MPH · University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2017-02-01

Completion

2019-06-01

Countries

• United States
• Canada

Study Locations