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

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00573898
First received: December 12, 2007
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

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.


Condition
Renal Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pharmacokinetics of Daptomycin in Patients Receiving Continuous Veno-Venous Hemodiafiltration (CVVHDF)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

All of your biologic samples will be under the control of the principal investigator of this research project. To protect your confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. Samples will be kept in the investigator's laboratory located in Scaife Hall, room 812, 3500 Terrace Street. You may request to have your samples destroyed if you withdraw. The request must be in writing and samples collected and not already processed will be destroyed.


Estimated Enrollment: 5
Study Start Date: March 2008
Study Completion Date: December 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients receiving daptomycin

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573898

Locations
United States, Pennsylvania
UPMC
PIttsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Heather Johnson, Pharm D University of Pittsburgh
  More Information

No publications provided

Responsible Party: Heather Johnson, Pharm D, UPMC
ClinicalTrials.gov Identifier: NCT00573898     History of Changes
Other Study ID Numbers: PRO07060252
Study First Received: December 12, 2007
Last Updated: February 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
daptomycin

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014