Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2010 by University of Zurich.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Zurich

ClinicalTrials.gov Identifier:

NCT01171547

First received: July 22, 2010

Last updated: July 27, 2010

Last verified: July 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 22, 2010
Last Updated Date	July 27, 2010
Start Date ^ICMJE	February 2010
Estimated Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 27, 2010)	Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing. [ Time Frame: PK on days 1, 3, and 5 ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01171547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration
Official Title ^ICMJE	Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Bacteremia
Intervention ^ICMJE	Drug: Daptomycin once daily over 5 days
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	15
Completion Date	Not Provided
Estimated Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01171547
Other Study ID Numbers ^ICMJE	EK-1632
Has Data Monitoring Committee	Yes
Responsible Party	Prof. Marco Maggiorini, MD, Medical Intensive Care Unit
Study Sponsor ^ICMJE	University of Zurich
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Zurich
Verification Date	July 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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