Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD) - Full Text View

Sponsors and Collaborators:	University of Michigan Cubist Pharmaceuticals
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00663403

Purpose

Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.

Condition	Intervention	Phase
Critically Ill Hemodialysis	Drug: Daptomycin	Phase IV

MedlinePlus related topics: Antibiotics Dialysis Kidney Failure

Drug Information available for: Daptomycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)

Further study details as provided by University of Michigan:

Primary Outcome Measures:

To quantify daptomycin removal by continuous veno-venous hemodialysis. [ Time Frame: From time of drug administration to 48 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To characterize the pharmacokinetic parameters of daptomycin in critically ill patients with acute renal failure while being treated with continuous veno-venous hemodialysis. [ Time Frame: From time of drug administration to 48 hours post dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	8
Study Start Date:	February 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Daptomycin Daptomycin 8 mg/kg IV q48h.

Detailed Description:

Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within therapeutic ranges, as previously identified, in critically ill patients with acute renal failure treated with continuous hemodialysis.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

=/> 18 years of age
Prescribed CVVHD as determined by the primary physician
Prescribed daptomycin as determined by the primary physician
Informed consent granted

Exclusion Criteria:

< 18 years of age
Allergy to daptomycin
Patients being primarily treated with daptomycin for diagnosis of osteomyelitis, meningitis, or pneumonia without adequate concomitant use of other more effective antimicrobial agents as daptomycin is not indicated for primary treatment of these types of infections
Inability to complete 48 hours of CVVHD
Concurrent use of other extracorporeal therapies such as ECMO or plasmapheresis and intermittent hemodialysis
Inability to obtain informed consent
Pregnant and/or breastfeeding women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663403

Contacts

Contact: Daryl D DePestel, PharmD

734-936-2473

daryldd@umich.edu

Locations

United States, Michigan
University of Michigan University Hospital	Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Bruce A Mueller, PharmD

Sponsors and Collaborators

University of Michigan

Cubist Pharmaceuticals

Investigators

Principal Investigator:

Bruce A Mueller, PharmD

University of Michigan, College of Pharmacy

More Information

No publications provided

Responsible Party:	University of Michigan, College of Pharmacy ( Bruce A. Mueller )
Study ID Numbers:	063940, HUM00005646
Study First Received:	April 18, 2008
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00663403 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Michigan:

daptomycin
pharmacokinetics
renal replacement therapy
critical illness
intensive care units

Study placed in the following topic categories:

Daptomycin
Anti-Bacterial Agents
Critical Illness

Additional relevant MeSH terms:

Daptomycin
Anti-Infective Agents
Anti-Bacterial Agents
Disease Attributes

Pathologic Processes
Critical Illness
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009