Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy

PHASE3CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

March 31, 2018

Study Completion Date

December 31, 2018

Conditions
Kidney Stones
Interventions
DRUG

cephalosporins

Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference. Ancef, a 1st generation cephalosporin, was used as the primary antibiotic, which was started within 60 minutes of the procedure. Dosing was 1 gram IV every 8 hours and was adjusted for renal dosing as needed

DRUG

Fluoroquinolones

If the patient has an allergy to penicillin or cephalosporin, then Ciprofloxacin was used instead and started within 120 minutes of the procedure at 400mg IV and would be continued every 12hrs if patient has a normal creatinine clearance

DRUG

Clindamycin

If allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision.

DRUG

Ampicillin/Gentamicin

5 mg/kg as a single dose of Gentamicin within 60 minutes prior to surgical incision; given in combination with 2 grams of ampicillin in cases where allergic to fluoroquinolone and cephalosporin

Trial Locations (2)

11030

North Shore University Hospital, Manhasset

11040

Long Island Jewish Medical Center, New Hyde Park

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Northwell Health

OTHER