Working… Menu

Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation

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: NCT01666769
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : November 5, 2019
Information provided by (Responsible Party):
Kevin Watt, Duke University

Brief Summary:
Determine proper dosing of micafungin in children supported with extracorporeal membrane oxygenation (ECMO).

Condition or disease Intervention/treatment Phase
Invasive Candidiasis Drug: Micafungin Phase 1

Detailed Description:

Extracorporeal membrane oxygenation (ECMO) is a cardiopulmonary bypass device that provides life-saving, complete respiratory and cardiac support for children who suffer refractory heart or lung failure. While on ECMO, children are at increased risk of infection, including fungal infection. Antifungal prophylaxis can potentially reduce the burden of disease in children on ECMO. Because fungal infections can result in biofilms that are difficult to treat, treatment includes not only antifungal medications but also removal of any large intravenous lines. However, catheter removal for children on ECMO is impossible; therefore, therapy relies upon optimal antifungal management alone.

Micafungin is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Micafungin may be particularly efficacious in children on ECMO because of the drug's ability to penetrate biofilms. However, the ECMO circuit is known to substantially alter drug levels for many drugs, resulting in important dosing changes. Appropriate micafungin dosing in this setting is unknown and sub-optimal dosing might result in therapeutic and prophylactic failure.

Standard dosing of micafungin are 4 and 2 mg per kilogram of body weight given intravenously once daily for treatment and prophylaxis, respectively. Based on preliminary data and modeling from other studies, investigators hypothesize that 8 and 4 mg per kilogram given once daily will achieve proper drug levels to respectively treat and prevent fungal infections in children under 2 years of age who are supported by ECMO. Because the ECMO circuit should have less of an impact on volume of distribution in larger children, investigators hypothesize that in children from 2 to 18 years old, standard dosing of micafungin will achieve proper drug concentrations.

Investigators hold the FDA investigational new drug application (IND #115255) to give micafungin to children on ECMO at the doses described above. Blood samples will be collected at specific times around the first and fourth micafungin doses to describe the pharmacokinetics and drug extraction by the ECMO circuit.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics of Micafungin in Children Supported With Extracorporeal Membrane Oxygenation
Actual Study Start Date : January 2013
Actual Primary Completion Date : February 2, 2016
Actual Study Completion Date : February 9, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Treatment Dosing
Age group: 0 - <2y, Micafungin 8 mg/kg/day IV
Drug: Micafungin
8 mg/kg/day
Other Name: Mycamine

Prophylaxis dosing
Age group: 0-<2y, Micafungin 4 mg/kg/day IV
Drug: Micafungin
4 mg/kg/day
Other Name: Mycamine

Standard of care Dosing
Age group: 2-17.85 y, Micafungin standard of care dosing (decided by treating physician)
Drug: Micafungin
Standard of care Dosing
Other Name: Mycamine

Primary Outcome Measures :
  1. Pharmacokinetic primary endpoints [ Time Frame: Around the first and fourth doses of micafungin: 0-4h prior to and 0-30 min, 60-90 min, 2-4h, 8-10h, 12-16h, 22-24h after infusion of study drug ]
    Clearance rate (CL), Volume of distribution (V), Oxygenator extraction efficacy

Secondary Outcome Measures :
  1. Safety [ Time Frame: From Dose 1 until 7 days after the last dose ]
    Number of adverse events (any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • <= 17.85 years at the time of enrollment.
  • Sufficient venous access to permit administration of study medication.
  • Supported with either venoarterial (VA) or venovenous (VV) ECMO.
  • Availability and willingness of the parent/legal guardian to provide written informed consent.
  • For treatment dosing arm: confirmed or suspected infection

Exclusion Criteria:

  • Subject with a history of anaphylaxis attributed to an echinocandin.
  • Any other concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
  • Previous participation in this study.
  • 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): NCT01666769

Layout table for location information
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Kevin Watt
Layout table for investigator information
Principal Investigator: Kevin Watt, MD Duke Clinical Research Institute
Layout table for additonal information
Responsible Party: Kevin Watt, Assistant Professor, Duke University Identifier: NCT01666769    
Other Study ID Numbers: Pro00039552
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Keywords provided by Kevin Watt, Duke University:
Extracorporeal membrane oxygenation
Extracorporeal life support
Additional relevant MeSH terms:
Layout table for MeSH terms
Candidiasis, Invasive
Invasive Fungal Infections
Antifungal Agents
Anti-Infective Agents