Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

University of Zurich (UZH)

Status and phase: Unknown; Phase 2

Conditions: Bacteremia

Treatments: Drug: Daptomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01171547

EK-1632

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)