Status:
UNKNOWN
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study
Lead Sponsor:
University of Zurich
Conditions:
Gram-Positive Bacterial Infections
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
Daptomycin kinetics in CRRT * Trial with medicinal product
Eligibility Criteria
Inclusion
- 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
- Life expectancy of less than 5 days
Exclusion
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01212432
Start Date
December 1 2009
End Date
March 1 2010
Last Update
October 18 2010
Active Locations (1)
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1
Zurich, Switzerland