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

NCT01169402 | Completed Phase 1

• 1 other identifier: Pro00022822
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Arrest; Fungal Infection

Keywords

extracorporeal membrane oxygenation; ECMO; extracorporeal life support; fluconazole; diflucan; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics/Pharmacodynamics

  Determine proper dosing of fluconazole in children supported with extracorporeal membrane oxygentation

  Quarterly

Study Arms (1)

Fluconazole

EXPERIMENTAL

Drug: Fluconazole

Interventions

Fluconazole DRUG

25mg/kg intravenously once weekly while on ECMO

Also known as: Diflucan

Fluconazole

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \<= 17.5 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.

You may not qualify if:

• Subject with a history of anaphylaxis attributed to an azole.
• 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.
• 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.
• Pregnancy

Sponsors & Collaborators

• Michael Cohen-Wolkowiez: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Arrest; Mycoses

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kevin M Watt, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 26, 2010
• Study Start: July 1, 2010
• Primary Completion: February 20, 2013
• Study Completion: February 20, 2013
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

US (1)