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

Candida Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818584
• Other study ID #: 9463-CL-2104
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2009
• Last updated: March 4, 2013
• Start date: August 2007
• Est. completion date: October 2007

Study information

• Verified date: March 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Other known NCT identifiers

• NCT00906230

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Days

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Candida

Intervention

Drug:
• Micafungin
IV Administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of micafungin plasma pharmacokinetic parameters		Day 4	No
Secondary	Monitor adverse events		11 or 12 Days	No

External Links

•   Link to results on JAPIC