Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients (STOP-NT)
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|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
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|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: Teflaro
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
600 mg IV/PO q12h
Other Name: Zyvox
- 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.
- 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.
- 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.
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
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48208|
|Principal Investigator:||Jose Vazquez, M.D.||Henry Ford Hospital|