Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01171547
Recruitment Status : Unknown
Verified July 2010 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : July 28, 2010
Last Update Posted : July 28, 2010
Information provided by:
University of Zurich

July 22, 2010
July 28, 2010
July 28, 2010
February 2010
February 2010   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study
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.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Daptomycin
once daily over 5 days
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
February 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Prof. Marco Maggiorini, MD, Medical Intensive Care Unit
University of Zurich
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University of Zurich
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP