NCT01734694

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Health Care Associated Pneumonia
• Osteomyelitis/Septic Arthritis
• Endocarditis
• Bacteremia
• Acute Bacterial Skin and Skin Structure Infections

Interventions

Type	Name	Description
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;
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
DRUG	Linezolid	600 mg IV/PO q12h

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-11-28
• Last updated: 2023-05-03
• Results posted: 2023-05-03

Locations

1 site across 1 country: United States