Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Daptomycin

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