Status:
COMPLETED
Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)
Lead Sponsor:
Michael Cohen-Wolkowiez
Conditions:
Cardiopulmonary Arrest
Fungal Infection
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
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 revers...
Eligibility Criteria
Inclusion
- \<= 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01169402
Start Date
July 1 2010
End Date
February 20 2013
Last Update
November 22 2017
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710