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

Bacteremia Clinical Trial

— STOP-NT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01734694
• Other study ID #: 7089
• Status: Terminated
• Phase: Phase 4
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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;
• 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;
• 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
• Linezolid
600 mg IV/PO q12h

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Individuals With Nephrotoxicity	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.	Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.
Secondary	Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity	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) while on the study drug.; 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.	Day 1 and daily serum creatinine assessment up to date of discharge, and a median of 7 days.
Secondary	Proportion of Individuals With Clinical Success	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) while on the study drug.; 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.	Daily assessment of signs and symptoms of infection, and a median of 7 days.