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

NCT00663403 | Completed Phase 4 Results

• 2 other identifiers: 063940HUM00005646
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill; Hemodialysis

Keywords

daptomycin; pharmacokinetics; renal replacement therapy; critical illness; intensive care units

Outcome Measures

Primary Outcomes (1)

• Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis

  Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.

  From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis

Secondary Outcomes (6)

• Daptomycin Dose Actually Administered

  Time of daptomycin administration

• Observed Daptomycin Peak Serum Concentration

  At the end of the daptomycin intravenous infusion (at approximately 30 minutes)

• Daptomycin Volume of Distribution at Steady State

  From time of daptomycin administration to 48 hours post dose

• Daptomycin Total Body Clearance

  From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis

• Daptomycin Half-life

  From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis

Interventions

Daptomycin DRUG

Daptomcyin 8 mg/kg infused intravenously every 48 hours

Also known as: Cubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• =/\> 18 years of age
• Prescribed Continuous Venovenous Hemodialysis (CVVHD) as determined by the primary physician
• Prescribed daptomycin as determined by the primary physician
• Informed consent granted

You may not qualify if:

• \< 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 Continuous Venovenous Hemodialysis (CVVHD)
• Concurrent use of other extracorporeal therapies such as Extracorporeal Membrane Oxygenation (ECMO) or plasmapheresis and intermittent hemodialysis
• Inability to obtain informed consent
• Pregnant and/or breastfeeding women

Sponsors & Collaborators

• University of Michigan: lead
• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator

Study Sites (1)

University of Michigan University Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Vilay AM, Grio M, Depestel DD, Sowinski KM, Gao L, Heung M, Salama NN, Mueller BA. Daptomycin pharmacokinetics in critically ill patients receiving continuous venovenous hemodialysis. Crit Care Med. 2011 Jan;39(1):19-25. doi: 10.1097/CCM.0b013e3181fa36fb.

  PMID: 20890189 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Transmembrane and total body clearance results limited to continuous venovenous hemodialysis run at \~2 L/h dialysate flow. Clinical outcomes (such as infection cure rate, length of hospital stay, mortality rate) of subjects was not assessed.

Results Point of Contact

• Title: Bruce A. Mueller
• Organization: University of Michigan College of Pharmacy

muellerb@umich.edu

7347636629

Study Officials

• Bruce A Mueller, PharmD

  University of Michigan, College of Pharmacy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: February 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 30, 2015
• Results First Posted: August 26, 2010

Record last verified: 2009-05

Locations

US (1)