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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kevin Watt, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01169402
First received: July 22, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Cardiopulmonary Arrest
Fungal Infection
Drug: Fluconazole
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics of Fluconazole Prophylaxis in Children Supported With Extracorporeal Membrane Oxygenation

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Pharmacokinetics/Pharmacodynamics [ Time Frame: Quarterly ] [ Designated as safety issue: Yes ]
    Determine proper dosing of fluconazole in children supported with extracorporeal membrane oxygentation


Estimated Enrollment: 36
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluconazole Drug: Fluconazole
25mg/kg intravenously once weekly while on ECMO
Other Name: Diflucan

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169402

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Kevin Watt
Investigators
Principal Investigator: Kevin M Watt, MD Duke University
  More Information

No publications provided

Responsible Party: Kevin Watt, Assistant Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01169402     History of Changes
Other Study ID Numbers: Pro00022822
Study First Received: July 22, 2010
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
extracorporeal membrane oxygenation
ECMO
extracorporeal life support
fluconazole
diflucan
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Heart Arrest
Mycoses
Cardiovascular Diseases
Heart Diseases
Fluconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014