Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 2013 |
| Estimated Primary Completion Date: | June 2013 (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 |
Inclusion Criteria:
- <= 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.
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Kevin M Watt, MD | 919-668-7835 | kevin.watt@duke.edu |
| Contact: Michael Cohen-Wolkowiez, MD | 919-668-8812 | michael.cohenwolkowiez@duke.edu |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| 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: | October 18, 2012 |
| 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:
|
Mycoses Heart Arrest Heart Diseases Cardiovascular Diseases Fluconazole Antifungal Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013