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

Tracking Information

First Received Date ^ICMJE

April 18, 2008

Last Updated Date

May 11, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00663403 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)

Official Title ^ICMJE

Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)

Brief Summary

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.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Condition ^ICMJE

Critically Ill
Hemodialysis

Intervention ^ICMJE

Drug: Daptomycin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00663403

Responsible Party

Bruce A. Mueller, University of Michigan, College of Pharmacy

Study ID Numbers ^ICMJE

063940, HUM00005646

Study Sponsor ^ICMJE

University of Michigan

Collaborators ^ICMJE

Cubist Pharmaceuticals

Investigators ^ICMJE

Principal Investigator:

Bruce A Mueller, PharmD

University of Michigan, College of Pharmacy

Information Provided By

University of Michigan

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP