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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00818584

Purpose

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

Condition	Intervention	Phase
Candida	Drug: Micafungin	Phase I

Drug Information available for: Micafungin FK 463

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Assessment of micafungin plasma pharmacokinetic parameters [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Monitor adverse events [ Time Frame: 11 or 12 Days ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	August 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. micafungin lower dose: Experimental	Drug: Micafungin IV Administration
2. micafungin higher dose: Experimental	Drug: Micafungin IV Administration

Detailed Description:

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

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818584

Locations

United States, Alabama

Birmingham, Alabama, United States, 35233
United States, California

Orange, California, United States, 92868
United States, Kentucky

Louisville, Kentucky, United States, 40202
United States, Missouri

Kansas City, Missouri, United States, 64108
United States, North Carolina

Durham, North Carolina, United States, 27710
United States, Texas

Dallas, Texas, United States, 75390
United States, Virginia

Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trials Registry )
Study ID Numbers:	9463-CL-2104
Study First Received:	January 6, 2009
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00818584
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Micafungin
Candida
Neonates
Mycamine
FK463

Study placed in the following topic categories:

Clotrimazole
Miconazole
Tioconazole
Torulopsis
Micafungin

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009