Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Infectious Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 11/24/2017 |
| Start Date: | July 2010 |
| End Date: | February 20, 2013 |
Safety and Pharmacokinetics of Fluconazole Prophylaxis in Children Supported With Extracorporeal Membrane Oxygenation
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.
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.
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
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