Back to resultsDaptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study
Primary Purpose
Gram-Positive Bacterial Infections
Status
Unknown status
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Daptomycin
Sponsored by
About this trial
This is an interventional treatment trial for Gram-Positive Bacterial Infections focused on measuring Gram positive infection and CRRT
Eligibility 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
Sites / Locations
- Recruiting
Outcomes
Primary Outcome Measures
Pharmacokinetics
Secondary Outcome Measures
Full Information
NCT ID
NCT01212432
First Posted
September 29, 2010
Last Updated
October 15, 2010
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT01212432
Brief Title
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
5. Study Description
Brief Summary
Daptomycin kinetics in CRRT
Trial with medicinal product
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Positive Bacterial Infections
Keywords
Gram positive infection and CRRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Intervention Description
Daptomycin kinetics in CRRT
Primary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
2011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
01 Studienregister MasterAdmins
Phone
+41 (0)44 255 11 11
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
City
Zurich
Country
Switzerland
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study
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