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Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01169402
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : November 22, 2017
Information provided by (Responsible Party):
Michael Cohen-Wolkowiez, Duke University

Brief Summary:

Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. While on ECMO, children are at increased risk of infection, including fungal infection. Treatment for fungal infection includes not only antifungal medications but also removal of any large intravenous (IV) lines. Since ECMO requires large IV lines, proper treatment of fungal infections would be difficult if not impossible. The investigators believe that giving prophylactic antifungal medication to all children on ECMO may prevent fungal infections from developing in the first place.

Fluconazole is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Unfortunately, the ECMO machine has the potential to significantly alter the drug levels of medications so the investigators do not know the proper dose of Fluconazole to give children on ECMO. Standard dosing of fluconazole is 12mg per kilogram of body weight given intravenously once daily. Based on preliminary data and modeling from other studies, the investigators think 25mg per kilogram given once weekly will achieve proper drug levels to prevent fungal infections. The investigators have obtained FDA approval to give this dose of fluconazole to children on ECMO who are enrolled in the study. Blood samples will be collected at specific times around the first and second fluconazole doses to describe the PK and drug extraction by the ECMO circuit.

Condition or disease Intervention/treatment Phase
Cardiopulmonary Arrest Fungal Infection Drug: Fluconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics of Fluconazole Prophylaxis in Children Supported With Extracorporeal Membrane Oxygenation
Study Start Date : July 2010
Actual Primary Completion Date : February 20, 2013
Actual Study Completion Date : February 20, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole

Arm Intervention/treatment
Experimental: Fluconazole Drug: Fluconazole
25mg/kg intravenously once weekly while on ECMO
Other Name: Diflucan

Primary Outcome Measures :
  1. Pharmacokinetics/Pharmacodynamics [ Time Frame: Quarterly ]
    Determine proper dosing of fluconazole in children supported with extracorporeal membrane oxygentation

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. <= 17.5 years at the time of enrollment.
  2. Sufficient venous access to permit administration of study medication.
  3. Supported with either venoarterial (VA) or venovenous (VV) ECMO.
  4. Availability and willingness of the parent/legal guardian to provide written informed consent.

Exclusion Criteria:

  1. Subject with a history of anaphylaxis attributed to an azole.
  2. Any other concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
  3. Previous participation in this study.
  4. Subjects who are receiving or who have received cyclosporine, tacrolimus, or azithromycin in the 72 hours prior to first dose of study product require protocol chair notification prior to enrollment.
  5. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01169402

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Michael Cohen-Wolkowiez
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Principal Investigator: Kevin M Watt, MD Duke University
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Responsible Party: Michael Cohen-Wolkowiez, Associate Professor, Duke University Identifier: NCT01169402    
Other Study ID Numbers: Pro00022822
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Keywords provided by Michael Cohen-Wolkowiez, Duke University:
extracorporeal membrane oxygenation
extracorporeal life support
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors