Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy

Sponsor

Northwell Health (Other)

Overall Status

Unknown status

CT.gov ID

NCT02579161

Collaborator

(none)

290

Enrollment

Locations

Arms

Duration (Months)

145

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Investigators objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stones	Drug: cephalosporins Drug: aminoglycoside Drug: metronidazole Drug: Clindamycin Drug: aminoglycoside/ sulbactam Drug: Fluoroquinolones	Phase 3

Detailed Description

For large renal stone burdens and/or complex stones, Percutaneous Nephrolithotomy (PCNL) has become the mainstay for treatment, replacing open kidney stone surgery since it's introduction in 1976. However, PCNL is not without its complications, specifically infectious. The procedure carries up to 25% incidence of infectious complications with approximately 1% rate of severe sepsis even with completely sterile conditions. Therefore, the use of antibiotics becomes paramount, but to date there are no PNCL specific guidelines for the appropriate duration and class of antibiotics. This fact leaves the practicing urologists to their own subjective experiences to the guide them. In addition, in an age where there are increasing numbers of resistant microbes the judicious use of antibiotics is in even more paramount.

The investigators of this project, purpose a randomized intention to treat prospective study to explore the duration and type of antibiotics in a larger population then previously studied. The investigators hypothesize that there will be no difference in complications between two groups: 1) 24 hours of perioperative antibiotics versus 2) Continued antibiotics until the removal of any external catheters. The investigators will model the antibiotics choices and duration after the 2013 American Urological Association, (AUA) Urologic Surgery Antimicrobial Prophylaxis recommendations, modified by our local antibiogram as necessary. The investigators' objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. Our hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.

Antibiotic detail: cephalosporins or aminoglycoside + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone

Looking at the same drugs and doses the variable is the timeframe of the medication

Study Design

Study Type:

Interventional

Anticipated Enrollment :

290 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2019

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Antibiotics for a 24 hour period Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc.	Drug: cephalosporins Looking at the same drugs and doses the variable is the timeframe of the medication Other Names: or + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone Drug: aminoglycoside Drug: metronidazole Drug: Clindamycin Drug: aminoglycoside/ sulbactam If allergies to above medicines Drug: Fluoroquinolones
Active Comparator: Continued antibiotics Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc.	Drug: cephalosporins Looking at the same drugs and doses the variable is the timeframe of the medication Other Names: or + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone Drug: aminoglycoside Drug: metronidazole Drug: Clindamycin Drug: aminoglycoside/ sulbactam If allergies to above medicines Drug: Fluoroquinolones

Arm

Intervention/Treatment

Active Comparator: Antibiotics for a 24 hour period

Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc.

Drug: cephalosporins

Looking at the same drugs and doses the variable is the timeframe of the medication

Other Names:

or + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone

Drug: aminoglycoside

Drug: metronidazole

Drug: Clindamycin

Drug: aminoglycoside/ sulbactam

If allergies to above medicines

Drug: Fluoroquinolones

Active Comparator: Continued antibiotics

Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc.

Drug: cephalosporins

Looking at the same drugs and doses the variable is the timeframe of the medication

Other Names:

or + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone

Drug: aminoglycoside

Drug: metronidazole

Drug: Clindamycin

Drug: aminoglycoside/ sulbactam

If allergies to above medicines

Drug: Fluoroquinolones

Outcome Measures

Primary Outcome Measures

Efficacy of antibiotic dosing [2 years]
Compare the clinical efficacy of a single-dose protocol (antibiotics for 24 hours) with a short-course protocol (antibiotics continued until external catheters are removed) for PCNL. Looking at complication rate differences