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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00608335

Collaborator

(none)

Enrollment

Locations

Arms

46.8

Actual Duration (Months)

6.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Oropharyngeal Candidiasis Candidemia Invasive Candidiasis Esophageal Candidiasis	Drug: Micafungin	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Oct 14, 2007

Actual Primary Completion Date :

Sep 8, 2011

Actual Study Completion Date :

Sep 8, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1. Micafungin 3.0 mg IV	Drug: Micafungin IV Other Names: FK463
Experimental: 2. Micafungin 4.5 mg IV	Drug: Micafungin IV Other Names: FK463

Arm

Intervention/Treatment

Experimental: 1. Micafungin 3.0 mg

Drug: Micafungin

Other Names:

FK463

Experimental: 2. Micafungin 4.5 mg

Drug: Micafungin

Other Names:

FK463

Outcome Measures

Primary Outcome Measures

PK parameters (AUCtau, Tmax, and Cmax) [10 - 14 Days]

Secondary Outcome Measures

Adverse events [Day 1 to End of Study]
Vital signs [Day 1 to End of Study]
Hematology and chemistry laboratory tests [Day 1 to End of Study]
12-lead ECGs and Physical examination [Day 1 to End of Study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles Medical Center	Los Angeles	California	United States	90095
2	Children's Hospital of Orange County	Orange	California	United States	92868
3	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
4	Duke University Medical Center	Durham	North Carolina	United States	27710
5	Oregon Health and Science University	Portland	Oregon	United States	97239
6	University of Texas Southwestern	Dallas	Texas	United States	75390
7	Texas Children's Hospital	Houston	Texas	United States	77030
8	Benmed Park Clinic	Benoni		South Africa	1500
9	Grootte Schuur Hospital	Cape Town		South Africa	7924
10	GCT -Sunnyside Medi-clinic	Lynn East		South Africa	0039
11	St. Mary's Hospital	Mariannhill		South Africa	3610
12	Jubilee Hospital	Temba		South Africa	0400
13	2 Military Hospital	Wynberg		South Africa	7824