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NCT01212432 Clinical Trial

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

Gram-Positive Bacterial Infections Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01212432
Other study ID # DAPTO_CH08
Secondary ID
Status Recruiting
Phase Phase 2
First received September 29, 2010
Last updated October 15, 2010
Start date December 2009
Est. completion date March 2010

Study information
Verified date July 2010
Source University of Zurich
Contact 01 Studienregister MasterAdmins
Phone +41 (0)44 255 11 11
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

Daptomycin kinetics in CRRT

- Trial with medicinal product

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date March 2010
Est. primary completion date March 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

- Life expectancy of less than 5 days

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Daptomycin
Daptomycin kinetics in CRRT

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics 2011 Yes
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