Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

Overview

The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.

Full Title of Study: “Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2010

Interventions

  • Drug: Daptomycin
    • once daily over 5 days

Clinical Trial Outcome Measures

Primary Measures

  • Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.
    • Time Frame: PK on days 1, 3, and 5
    • 15 patients are devided in 3 cohorts of 5 patients each. PK data(measured on day 1, 3 and 5) of the first 5 patients receiving daptomycin 6mg/kg/day during 5 consecutive days additionally to standard antibiotic treatment are compared with PK data of daptomycin 6mg/kg/day in healthy volunteers and dose is adapted in the next 5 patients based on these results. The same is done for the last 5 patients.

Participating in This Clinical Trial

Inclusion Criteria

  • male or female of 18 years or older – females: negative pregnancy test – Hospitalisation in the medical ICU – High suspicion or evidence of Gram-positive infections requiring antibiotic therapy – Subjects receiving standard antibiotic treatment for Gram-positive infection – Evidence of renal failure – Clinical necessity for continuous renal replacement therapy – Written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign. Exclusion Criteria:

  • Skeletal muscle disorders or CPK levels of > 2 x ULN – History of hypersensitivity to the drug – Participation in another study – Subjects with a history of muscle disease – Patients with severe liver function impairment (Child C) – Life expectancy of less than 5 days

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Prof. Marco Maggiorini, MD, Medical Intensive Care Unit

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