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

Phase 1

Completed

• Conditions: Oropharyngeal Candidiasis; Candidemia; Invasive Candidiasis; Esophageal Candidiasis
• Interventions: Drug: Micafungin

• Registration Number: NCT00608335
• Lead Sponsor: Astellas Pharma Inc

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.

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 Timeline

• Study Start: 2007-10-14
• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-01-23
• Study First Posted: 2008-02-06
• Primary Completion: 2011-09-08
• Study Completion: 2011-09-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Subject is 2 to 16 years inclusive
2. Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
3. Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables

Exclusion Criteria

1. 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)
2. Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
3. Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
4. Subject has received treatment with an echinocandin within one week prior to first dosing
5. Subject status is unstable and subject is unlikely to complete all study required procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1. Micafungin 3.0 mg	Micafungin	IV
2. Micafungin 4.5 mg	Micafungin	IV

Primary Outcome Measures

Name	Time	Method
PK parameters (AUCtau, Tmax, and Cmax)	10 - 14 Days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

University of California Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Grootte Schuur Hospital; 🇿🇦 Cape Town, South Africa

Benmed Park Clinic; 🇿🇦 Benoni, South Africa

GCT -Sunnyside Medi-clinic; 🇿🇦 Lynn East, South Africa

Jubilee Hospital; 🇿🇦 Temba, South Africa

2 Military Hospital; 🇿🇦 Wynberg, South Africa

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

St. Mary's Hospital; 🇿🇦 Mariannhill, South Africa

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States