Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-09-30

Brief Summary

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For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.

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Detailed Description

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Conditions

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Health Care Associated Pneumonia Osteomyelitis/Septic Arthritis Endocarditis Bacteremia Acute Bacterial Skin and Skin Structure Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vancomycin

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;

Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;

Comparator

Group Type ACTIVE_COMPARATOR

Ceftaroline

Intervention Type DRUG

Dose based on package insert labeling

CrCL \> 50 mL/min: 600 mg IV q12h

CrCL 31-50 mL/min: 400 mg q12h

CrCL 15-30 mL/min: 300 mg q12h

CrCL \< 15mL/min: 200 mg q12h;

Daptomycin

Intervention Type DRUG

Dose based on renal function and literature dosing recommendations

CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h

CrCL \< 30 mL/min: 6 - 10 mg/kg IV q48h

Linezolid

Intervention Type DRUG

600 mg IV/PO q12h

Interventions

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Vancomycin

Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;

Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;

Intervention Type DRUG

Ceftaroline

Dose based on package insert labeling

CrCL \> 50 mL/min: 600 mg IV q12h

CrCL 31-50 mL/min: 400 mg q12h

CrCL 15-30 mL/min: 300 mg q12h

CrCL \< 15mL/min: 200 mg q12h;

Intervention Type DRUG

Daptomycin

Dose based on renal function and literature dosing recommendations

CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h

CrCL \< 30 mL/min: 6 - 10 mg/kg IV q48h

Intervention Type DRUG

Linezolid

600 mg IV/PO q12h

Intervention Type DRUG

Other Intervention Names

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Teflaro Cubicin Zyvox

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or older
* Receiving intravenous vancomycin for the treatment of healthcare associated pneumonia, osteomyelitis/septic arthritis, endocarditis/bacteremia, or acute bacterial skin and skin structure infections
* Expected to receive vancomycin for at least 72 hours and are within the first 72 hours of therapy
* Have at least two or more of the following risk factors for drug-induced nephrotoxicity: a) receipt high-dose vancomycin therapy (greater than or equal to four grams per day) b) receipt of vasopressors c) receipt of nephrotoxic drugs (i.e. aminoglycosides, furosemide, acyclovir, amphotericin b, colistin, and intravenous contrast dye) d) pre-existing renal dysfunction (i.e. SCr greater than or equal to 1.5 mg/dL).

Exclusion Criteria

* Pregnancy
* End-stage renal disease
* Receipt of more than 4 grams of vancomycin prior to enrollment on current admission
* Absolute neutrophil count \< 1000/mm3

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No