Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study

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:
NCT01212432
First received: September 29, 2010
Last updated: October 15, 2010
Last verified: July 2010
  Purpose

Daptomycin kinetics in CRRT

  • Trial with medicinal product

Condition Intervention Phase
Gram-Positive Bacterial Infections
Drug: Daptomycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: December 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Daptomycin
    Daptomycin kinetics in CRRT
  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
  • Life expectancy of less than 5 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212432

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Maggiorini Marco, Prof. Dr. med., University Hospital Zurich, Intensivmedizin
ClinicalTrials.gov Identifier: NCT01212432     History of Changes
Other Study ID Numbers: DAPTO_CH08
Study First Received: September 29, 2010
Last Updated: October 15, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Gram positive infection and CRRT

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014