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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
History of Changes
  Purpose

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 Intervention Phase
Bacteremia
 Drug: Daptomycin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study

Resource links provided by NLM:

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

Further study details as provided by University of Zurich:

Primary Outcome 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 ] [ 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.


Estimated Enrollment: 15
Study Start Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Daptomycin
    once daily over 5 days
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Prof. Marco Maggiorini, MD, Medical Intensive Care Unit
ClinicalTrials.gov Identifier: NCT01171547     History of Changes
Other Study ID Numbers: EK-1632
Study First Received: July 22, 2010
Last Updated: July 27, 2010
Health Authority: Switzerland: Ethikkommission

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013