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An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Candida

Intervention: Micafungin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.


This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection

Clinical Details

Official title: A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Assessment of micafungin plasma pharmacokinetic parameters

Secondary outcome: Monitor adverse events

Detailed description: Subjects will be stratified by weight to receive one of two doses of study drug


Minimum age: N/A. Maximum age: 120 Days. Gender(s): Both.


Inclusion Criteria:

- Informed consent and HIPAA authorization of the infant's parent or legally authorized

representative must be obtained prior to study entry

- Infant has sufficient venous access to permit study drug dosing

- Infant is suspected to have a systemic Candida infection and appropriate cultures

(blood with or without urine/CSF) are obtained at the time of study entry Exclusion Criteria:

- Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the

echinocandin class of antifungals

- Infant has received an echinocandin within one month prior to study entry

- Infant has a concomitant medical condition which, in the opinion of the investigator

and/or medical advisor, may create an unacceptable additional risk

- Infant has a life expectancy of less than 96 hours

Locations and Contacts

Birmingham, Alabama 35233, United States

Orange, California 92868, United States

Louisville, Kentucky 40202, United States

Kansas City, Missouri 64108, United States

Durham, North Carolina 27710, United States

Dallas, Texas 75390, United States

Charlottesville, Virginia 22908, United States

Additional Information

Link to results on JAPIC

Related publications:

Benjamin DK Jr, Smith PB, Arrieta A, Castro L, Sánchez PJ, Kaufman D, Arnold LJ, Kovanda LL, Sawamoto T, Buell DN, Hope WW, Walsh TJ. Safety and pharmacokinetics of repeat-dose micafungin in young infants. Clin Pharmacol Ther. 2010 Jan;87(1):93-9. doi: 10.1038/clpt.2009.200. Epub 2009 Nov 4.

Starting date: August 2007
Last updated: March 4, 2013

Page last updated: August 23, 2015

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