Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Bacteremia
- Sponsor
- University of Zurich
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.
- Last Updated
- 15 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
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.