Back to resultsDaptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration
Primary Purpose
Bacteremia
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 Bacteremia focused on measuring pharmacokinetics
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 C)
- Life expectancy of less than 5 days
Sites / Locations
- Medical Intensive Care Unit, University Hospital ZurichRecruiting
Outcomes
Primary Outcome Measures
Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01171547
Brief Title
Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration
Official Title
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia
Keywords
pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial 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
once daily over 5 days
Primary Outcome Measure Information:
Title
Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.
Description
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.
Time Frame
PK on days 1, 3, and 5
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 C)
Life expectancy of less than 5 days
Facility Information:
Facility Name
Medical Intensive Care Unit, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maggiorini, Prof
Email
marco.maggiorini@usz.ch
12. IPD Sharing Statement
Learn more about this trial
Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration
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