Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients (STOP-NT)

This study has been terminated.
(Independent biostatistician recommended early termination of the trial due to low probability of success.)
Sponsor:
Information provided by (Responsible Party):
Jose Vazquez, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01734694
First received: November 14, 2012
Last updated: July 8, 2013
Last verified: July 2013

November 14, 2012
July 8, 2013
October 2011
September 2013   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01734694 on ClinicalTrials.gov Archive Site
  • 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.

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

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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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Health Care Associated Pneumonia
  • Osteomyelitis/Septic Arthritis
  • Endocarditis
  • Bacteremia
  • Acute Bacterial Skin and Skin Structure Infections
  • Drug: 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;

  • 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;

    Other Name: Teflaro
  • 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

    Other Name: Cubicin
  • Drug: Linezolid
    600 mg IV/PO q12h
    Other Name: Zyvox
  • Active Comparator: Vancomycin
    Intervention: Drug: Vancomycin
  • Active Comparator: Comparator
    Interventions:
    • Drug: Ceftaroline
    • Drug: Daptomycin
    • Drug: Linezolid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
Not Provided
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01734694
7089
Not Provided
Jose Vazquez, Henry Ford Health System
Henry Ford Health System
Not Provided
Principal Investigator: Jose Vazquez, M.D. Henry Ford Hospital
Henry Ford Health System
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP