Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01171547
First received: July 22, 2010
Last updated: July 27, 2010
Last verified: July 2010

July 22, 2010
July 27, 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 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01171547 on ClinicalTrials.gov Archive Site
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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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Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Bacteremia
Drug: Daptomycin
once daily over 5 days
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
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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
Both
18 Years to 90 Years
No
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Switzerland
 
NCT01171547
EK-1632
Yes
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