Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00607763

Purpose

Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed

Condition	Intervention	Phase
Invasive Candidiasis Esophageal Candidiasis Oropharyngeal Candidiasis Candidemia	Drug: Micafungin (Mycamine)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders Fungal Infections Molds Yeast Infections

Drug Information available for: Micafungin sodium

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Evaluation of Micafungin pharmacokinetics [ Time Frame: 10 - 14 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	October 2007
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1. Micafungin	Drug: Micafungin (Mycamine) IV Other Name: FK463

Detailed Description:

This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment) at a daily dose of 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood samples for assessment of pharmacokinetics will be collected.

Eligibility

Ages Eligible for Study:	4 Months to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is ≥4 months to < 24 months
Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables

Exclusion Criteria:

Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase > 5 times the upper limit of normal (ULN)
Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
Subject has received treatment with an echinocandin within one week prior to first dosing
Subject status is unstable and subject is unlikely to complete all study required procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607763

Locations

United States, California

Los Angeles, California, United States, 90095

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

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

Kansas City, Missouri, United States, 64108
United States, Texas

Dallas, Texas, United States, 75390

Houston, Texas, United States, 77030

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Sr Manager Clinical Trial Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier:	NCT00607763 History of Changes
Other Study ID Numbers:	9463-CL-2102
Study First Received:	January 23, 2008
Last Updated:	December 3, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Antifungal
Echinocandin
Candidiasis
Micafungin

Additional relevant MeSH terms:

Candidiasis
Esophageal Diseases
Candidemia
Candidiasis, Invasive
Mycoses
Gastrointestinal Diseases
Digestive System Diseases
Fungemia
Sepsis

Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Micafungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2012