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Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
University of Zurich

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bacteremia Drug: Daptomycin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study
Study Start Date : February 2010
Estimated Primary Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Daptomycin
U.S. FDA Resources


Intervention Details:
    Drug: Daptomycin
    once daily over 5 days


Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171547


Locations
Switzerland
Medical Intensive Care Unit, University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Maggiorini, Prof       marco.maggiorini@usz.ch   
Sponsors and Collaborators
University of Zurich

Responsible Party: Prof. Marco Maggiorini, MD, Medical Intensive Care Unit
ClinicalTrials.gov Identifier: NCT01171547     History of Changes
Other Study ID Numbers: EK-1632
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: July 2010

Keywords provided by University of Zurich:
pharmacokinetics

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents