Status:

COMPLETED

Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)

Lead Sponsor:

University of Michigan

Collaborating Sponsors:

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Conditions:

Critically Ill

Hemodialysis

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the...

Detailed Description

Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from thi...

Eligibility Criteria

Inclusion

  • =/\> 18 years of age
  • Prescribed Continuous Venovenous Hemodialysis (CVVHD) as determined by the primary physician
  • Prescribed daptomycin as determined by the primary physician
  • Informed consent granted

Exclusion

  • \< 18 years of age
  • Allergy to daptomycin
  • Patients being primarily treated with daptomycin for diagnosis of osteomyelitis, meningitis, or pneumonia without adequate concomitant use of other more effective antimicrobial agents as daptomycin is not indicated for primary treatment of these types of infections
  • Inability to complete 48 hours of Continuous Venovenous Hemodialysis (CVVHD)
  • Concurrent use of other extracorporeal therapies such as Extracorporeal Membrane Oxygenation (ECMO) or plasmapheresis and intermittent hemodialysis
  • Inability to obtain informed consent
  • Pregnant and/or breastfeeding women

Key Trial Info

Start Date :

February 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2009

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT00663403

Start Date

February 1 2007

End Date

April 1 2009

Last Update

December 30 2015

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Michigan University Hospital

Ann Arbor, Michigan, United States, 48109