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

Purpose

Children with fungal infections will be divided into two groups by weight. Children weighing < 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing > 25 kg.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety 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 Children (2-5 Years AND 6-11 Years) And Adolescents (12-16 Years) 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 Micafungin

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

PK parameters (AUCtau, Tmax, and Cmax) [ Time Frame: 10 - 14 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
Vital signs [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
Hematology and chemistry laboratory tests [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
12-lead ECGs and Physical examination [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]

Enrollment:	84
Study Start Date:	October 2007
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1. Micafungin 3.0 mg	Drug: Micafungin IV Other Name: FK463
Experimental: 2. Micafungin 4.5 mg	Drug: Micafungin IV Other Name: FK463

Detailed Description:

This is a prospective, multicenter, open-label, repeat-dose study conducted in two groups. Subjects in Group 1 and Group 2 will receive treatment for 10 to 14 days (per investigator clinical judgment); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's weight at baseline. Study procedures in both groups will be similar except that serial blood samples for assessment of pharmacokinetics will be collected in Group 1. Subjects may only participate in one group of the study.

At least 24 subjects, with at least 8 in each of three age ranges, will be enrolled in Group 1 (PK + safety). At least 36 subjects will be enrolled in Group 2 (safety), with at least 12 in each of the three age ranges.

Eligibility

Ages Eligible for Study:	2 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is 2 to 16 years inclusive
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: NCT00608335

Locations

United States, California
University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Texas Children's Hospital
Houston, Texas, United States, 77030
South Africa
Benmed Park Clinic
Benoni, South Africa, 1500
Grootte Schuur Hospital
Cape Town, South Africa, 7924
GCT -Sunnyside Medi-clinic
Lynn East, South Africa, 0039
St. Mary's Hospital
Mariannhill, South Africa, 3610
Jubilee Hospital
Temba, South Africa, 0400
2 Military Hospital
Wynberg, South Africa, 7824

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Senior Medical Director

Astellas Pharma Global Development

More Information

Additional Information:

Link to results on JAPIC This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00608335 History of Changes
Other Study ID Numbers:	9463-CL-2101
Study First Received:	January 23, 2008
Last Updated:	March 12, 2013
Health Authority:	United States: Food and Drug Administration South Africa: Medicines Control Council

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 19, 2013