Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
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
1 other identifier
interventional
84
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2007
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2007
CompletedFirst Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2011
CompletedNovember 18, 2024
November 1, 2024
3.9 years
January 23, 2008
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK parameters (AUCtau, Tmax, and Cmax)
10 - 14 Days
Secondary Outcomes (4)
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
Study Arms (2)
1. Micafungin 3.0 mg
EXPERIMENTALIV
2. Micafungin 4.5 mg
EXPERIMENTALIV
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of California Los Angeles Medical Center
Los Angeles, California, 90095, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Benmed Park Clinic
Benoni, 1500, South Africa
Grootte Schuur Hospital
Cape Town, 7924, South Africa
GCT -Sunnyside Medi-clinic
Lynn East, 0039, South Africa
St. Mary's Hospital
Mariannhill, 3610, South Africa
Jubilee Hospital
Themba, 0400, South Africa
2 Military Hospital
Wynberg, 7824, South Africa
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2008
First Posted
February 6, 2008
Study Start
October 14, 2007
Primary Completion
September 8, 2011
Study Completion
September 8, 2011
Last Updated
November 18, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.