Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients (STOP-NT)
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.
Health Care Associated Pneumonia
Acute Bacterial Skin and Skin Structure Infections
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients|
- Nephrotoxicity [ Time Frame: Day 1 and daily serum creatinine assessment up to date of discharge ] [ Designated as safety issue: Yes ]
Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days.
This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.
- Acute Kidney Injury Network Modified Definition of Nephrotoxicity [ Time Frame: Day 1 and daily serum creatinine assessment up to date of discharge ] [ Designated as safety issue: Yes ]
An abrupt (within 48 hour) reduction in kidney function with one or more of the following 1) Increase in SCr ≥ 0.3 mg/dL 2) Increase SCr ≥ 50% or 3) Decreased urine output (< 0.5 ml/kg/hr x 6 hrs).
This measure will be reported as proportion of patients with acute kidney injury within each group in relation to the number of patients in each group.
- Clinical Success [ Time Frame: Daily assessment of signs and symptoms of infection ] [ Designated as safety issue: No ]
Clinical success is a composite endpoint of those patients with clinical cure or improvement in clinical signs and symptoms of infection (i.e. SIRS criteria, and microbiology).
This measure will be reported as the proportion of patients with clinical success in each group compared to the the total number of patients in the group.
|Study Start Date:||October 2011|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: 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;
|Active Comparator: Comparator||
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;
Other Name: TeflaroDrug: 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
Other Name: CubicinDrug: Linezolid
600 mg IV/PO q12h
Other Name: Zyvox