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 I

MedlinePlus related topics:

Esophagus Disorders Fungal Infections Molds Yeast Infections

ChemIDplus related topics:

Clotrimazole Miconazole Miconazole nitrate Tioconazole Micafungin FK 463

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Non-Randomized, Open Label, Single Group Assignment, Safety Study

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

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 ]

Estimated Enrollment:	60
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 3.0mg	Drug: Micafungin IV
2: Experimental 4.5mg	Drug: Micafungin IV

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.

A total of 24 subjects, 8 in each of three age ranges, will be enrolled in Group 1 (PK + safety). Enrollment in an individual age cohort in Group 1 will complete before enrollment in the same age cohort in Group 2 can begin. A total of 36 subjects, 12 in each of three age ranges, will be enrolled in Group 2 (safety).

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 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

Contacts


Contact: Astellas Pharma US Medical Information	800-888-7704 ext 5473	clintrials.info@us.astellas.com

Locations


United States, California
		Recruiting
	Orange, California, United States, 92868

United States, Minnesota
		Recruiting
	Minneapolis, Minnesota, United States, 55455

United States, Missouri
		Recruiting
	Kansas City, Missouri, United States, 64108

United States, North Carolina
		Recruiting
	Durham, North Carolina, United States, 27710

United States, Texas
		Recruiting
	Dallas, Texas, United States, 75390
		Recruiting
	Houston, Texas, United States, 77030

South Africa
		Recruiting
	Lynn East, South Africa, 0039
		Recruiting
	Benoni, South Africa, 1500
		Terminated
	Mariannhill, South Africa, 3610
		Recruiting
	Wynberg, South Africa, 7824
		Terminated
	Temba, South Africa, 0400
		Recruiting
	Cape Town, South Africa, 7924

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Director:	Central Contact	Astellas Pharma US, Inc.

More Information

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trial Registry )
Study ID Numbers:	9463-CL-2101
First Received:	January 23, 2008
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00608335
Health Authority:	United States: Food and Drug Administration; South Africa: Medicines Control Council

Keywords provided by Astellas Pharma Inc:

Antifungal

Echinocandin

Candidiasis

Micafungin

Study placed in the following topic categories:

Mycoses

Digestive System Diseases

Esophageal disorder

Candidiasis

Clotrimazole

Gastrointestinal Diseases

Miconazole

Tioconazole

Esophageal Diseases

Micafungin

Additional relevant MeSH terms:

Anti-Infective Agents

Therapeutic Uses

Antifungal Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00608335