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Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy

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ClinicalTrials.gov Identifier: NCT02579161
Recruitment Status : Unknown
Verified August 2018 by Zeph Okeke, Northwell Health.
Recruitment status was:  Recruiting
First Posted : October 19, 2015
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Zeph Okeke, Northwell Health

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: 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 Name: 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



Primary Outcome Measures :
  1. Efficacy of antibiotic dosing [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients >18 years old
  • Negative urine culture within 1 month prior to procedure
  • Renal Calculi which would optimally require PCNL for treatment.

Exclusion Criteria:

  • Patients <18 years old.
  • Patients who are not able to give consent for study
  • Patients currently on antibiotics immediately prior to the procedure
  • Previous history of sepsis or SIRS from stone manipulations
  • Foley catheter in place for greater than 1 week duration
  • Patients under going planned, multi-staged procedures
  • Immunosuppressed patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579161


Locations
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United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Zeph Okeke, MD    516-734-8500    Zokek@nshs.edu   
Contact: Dave Leavitt, MD    516-734-8500    Dleavitt@nshs.edu   
Principal Investigator: Zeph Okeke, MD         
Sub-Investigator: Dave Leavitt, MD         
Sub-Investigator: Bradley Morganstern, MD         
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Zeph Okeke, MD    516-734-8500    zokeke@nshs.edu   
Principal Investigator: Zeph Okeke, MD         
Sub-Investigator: David Leavitt, MD         
Sub-Investigator: Bradley Morganstern, MD         
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Zeph Okeke, MD Northwell Health
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Responsible Party: Zeph Okeke, Principle Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT02579161    
Other Study ID Numbers: 14-003
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Keywords provided by Zeph Okeke, Northwell Health:
Percutaneous Nephrolithotomy
Kidney Stones
Antibiotics
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Metronidazole
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Sulbactam
Cephalosporins
Fluoroquinolones
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors
Nucleic Acid Synthesis Inhibitors