Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

Phase 2

• Conditions: Bacteremia

• Registration Number: NCT01171547
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-02
• Status Verified: 2010-07
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-27
• Last Update Submitted: 2010-07-27
• Study First Posted: 2010-07-28
• Last Update Posted: 2010-07-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.	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.

Trial Locations

Locations (1)

Medical Intensive Care Unit, University Hospital Zurich; 🇨🇭 Zurich, Switzerland