Daptomycin Study - Collection of Pharmacokinetic Samples in Patients With Renal Failure

Pharmacokinetics of Daptomycin in Patients Receiving Continuous Veno-Venous Hemodiafiltration (CVVHDF)

This will be a prospective, multicenter, open-labeled, non-comparative pharmacokinetic study conducted in 10 critically ill, anuric patients receiving CVVHDF. Enrollment will take place at 3-5 clinical sites in the United States. A study coordinator at each site will be identified and institutional specific processes (e.g., pharmacy records, etc.) will be utilized to identify patients. Full evaluation of inclusion and exclusion criteria will be conducted by each site's coordinator within 48 hours of initiation of daptomycin therapy. Subjects receiving daptomycin 6mg/kg (total body weight) once daily for a suspected/documented infection, as deemed necessary by the treating clinician will be screened for inclusion in the current study. Dialysate, ultrafiltrate, and blood flow rate utilized during the CVVHDF procedure will be determined by clinicians at discretion to optimize stability of patients.

Daptomycin samples will be obtained around the third dose in an attempt to achieve approximate steady-state concentrations. Pre- and post-filter blood samples will be collected simultaneously with dialysate and ultrafiltrate specimens at multiple time points. Protein binding will be assessed by filtration of the serum samples at the peak drug concentration time points.

Study Overview

• Status: Completed
• Conditions: Renal Failure

Detailed Description

Enrollment will take place at 3-5 clinical sites in the United States. Full evaluation of inclusion and exclusion criteria will be conducted by each site's coordinator within 48 hours of initiation of daptomycin therapy. Subjects receiving daptomycin 6mg/kg (total body weight) once daily for a suspected/documented infection, as deemed necessary by the treating clinician will be screened for inclusion in the current study. Dialysate, ultrafiltrate, and blood flow rate utilized during the CVVHDF procedure will be determined by clinicians at discretion to optimize stability of patients.

Daptomycin samples will be obtained around the third dose in an attempt to achieve approximate steady-state concentrations. Pre- and post-filter blood samples will be collected simultaneously with dialysate and ultrafiltrate specimens at multiple time points. Protein binding will be assessed by filtration of the serum samples at the peak drug concentration time points.

• Study Type: Observational
• Enrollment (Anticipated): 5

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • PIttsburgh, Pennsylvania, United States, 15213
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients receiving daptomycin

Description

Inclusion Criteria:

• This study will be conducted in adult critically ill patients receiving CVVHDF who are prescribed daptomycin 6mg/kg once daily as part of required medical care for suspected/documented infection, as deemed necessary by his or her treating clinician.

Exclusion Criteria:

• Daptomycin therapy will be chosen by the treating physician based on clinical indication and it is expected that risks of therapy will have already been considered; therefore, subjects are only to be excluded based on covariates that are expected to affect pharmacokinetics. Subjects will be excluded if they are:

  • less than 18 years of age
  • producing urine greater than 50 ml per 24 hours
  • have a life expectancy less than 96 hours
  • receiving CVVHDF utilizing rates or filters that are NOT otherwise considered "standard" by the enrolling site
  • receive less than 3 doses of daptomycin
  • participating in any other study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective of this study will be to determine the pharmacokinetic parameters of daptomycin 6mg/kg once daily in patients receiving CVVHDF, and the rate of drug clearance through the renal replacement apparatus.	2 years

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Heather Johnson, Pharm D, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 12, 2007
• First Submitted That Met QC Criteria: December 13, 2007
• First Posted (Estimate): December 14, 2007

Study Record Updates

• Last Update Posted (Estimate): February 18, 2011
• Last Update Submitted That Met QC Criteria: February 17, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: daptomycin
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: PRO07060252