Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation

• Status: Completed
• Trial end date: 2016-02-09
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kevin Watt
• Treatments: Echinocandins; Micafungin

Criteria

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