Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

Bacteremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01171547
• Other study ID #: EK-1632
• Status: Recruiting
• Phase: Phase 2
• First received: July 22, 2010
• Last updated: July 27, 2010
• Start date: February 2010

Study information

• Verified date: July 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacteremia

Intervention

Drug:
• Daptomycin
once daily over 5 days

Locations

Country	Name	City	State
Switzerland	Medical Intensive Care Unit, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	PK on days 1, 3, and 5	No