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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01734694
Recruitment Status : Terminated (Independent biostatistician recommended early termination of the trial due to low probability of success.)
First Posted : November 28, 2012
Last Update Posted : July 9, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Health Care Associated Pneumonia Osteomyelitis/Septic Arthritis Endocarditis Bacteremia Acute Bacterial Skin and Skin Structure Infections Drug: Vancomycin Drug: Ceftaroline Drug: Daptomycin Drug: Linezolid Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients
Study Start Date : October 2011
Estimated Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Vancomycin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Vancomycin 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;

Active Comparator: Comparator 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


Outcome Measures

Primary Outcome Measures :
  1. Nephrotoxicity [ Time Frame: Day 1 and daily serum creatinine assessment up to date of discharge ]

    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.



Secondary Outcome Measures :
  1. Acute Kidney Injury Network Modified Definition of Nephrotoxicity [ Time Frame: Day 1 and daily serum creatinine assessment up to date of discharge ]

    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.


  2. Clinical Success [ Time Frame: Daily assessment of signs and symptoms of infection ]

    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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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): NCT01734694


Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48208
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Jose Vazquez, M.D. Henry Ford Hospital
More Information

Responsible Party: Jose Vazquez, M.D., Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01734694     History of Changes
Other Study ID Numbers: 7089
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Pneumonia
Bacteremia
Endocarditis
Osteomyelitis
Arthritis, Infectious
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Vancomycin
Linezolid
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action