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

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:

NCT01212432

First received: September 29, 2010

Last updated: October 15, 2010

Last verified: July 2010

History of Changes

Purpose

Daptomycin kinetics in CRRT

Trial with medicinal product

Condition	Intervention	Phase
Gram-Positive Bacterial Infections	Drug: Daptomycin	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections

Drug Information available for: Daptomycin

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:

Pharmacokinetics [ Time Frame: 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	December 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Daptomycin kinetics in CRRT

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Life expectancy of less than 5 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212432

Contacts

Contact: 01 Studienregister MasterAdmins

+41 (0)44 255 11 11

Locations

Switzerland
	Recruiting
Zurich, Switzerland

Sponsors and Collaborators

University of Zurich

Investigators

Study Director:

01 Studienregister MasterAdmins

UniversitaetsSpital Zuerich

More Information

No publications provided

Responsible Party:	Maggiorini Marco, Prof. Dr. med., University Hospital Zurich, Intensivmedizin
ClinicalTrials.gov Identifier:	NCT01212432 History of Changes
Other Study ID Numbers:	DAPTO_CH08
Study First Received:	September 29, 2010
Last Updated:	October 15, 2010
Health Authority:	Switzerland: Swissmedic

Keywords provided by University of Zurich:

Gram positive infection and CRRT

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Daptomycin
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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