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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.
Details
| Lead sponsor | Henry Ford Health System |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 100 |
| Start date | 2011-10 |
| Completion | 2012-09 |
Conditions
- Health Care Associated Pneumonia
- Osteomyelitis/Septic Arthritis
- Endocarditis
- Bacteremia
- Acute Bacterial Skin and Skin Structure Infections
Interventions
- Vancomycin
- Ceftaroline
- Daptomycin
- Linezolid
Primary outcomes
- Proportion of Individuals With Nephrotoxicity — Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.
Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital. This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.
Countries
United States