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

Primary Purpose

Oropharyngeal Candidiasis, Candidemia, Invasive Candidiasis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Micafungin
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oropharyngeal Candidiasis focused on measuring Antifungal, Micafungin, Echinocandin, Candidiasis

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Los Angeles Medical Center
  • Children's Hospital of Orange County
  • Children's Mercy Hospital
  • Duke University Medical Center
  • Oregon Health and Science University
  • University of Texas Southwestern
  • Texas Children's Hospital
  • Benmed Park Clinic
  • Grootte Schuur Hospital
  • GCT -Sunnyside Medi-clinic
  • St. Mary's Hospital
  • Jubilee Hospital
  • 2 Military Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1. Micafungin 3.0 mg

2. Micafungin 4.5 mg

Arm Description

IV

IV

Outcomes

Primary Outcome Measures

PK parameters (AUCtau, Tmax, and Cmax)

Secondary Outcome Measures

Adverse events
Vital signs
Hematology and chemistry laboratory tests
12-lead ECGs and Physical examination

Full Information

First Posted
January 23, 2008
Last Updated
July 28, 2018
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00608335
Brief Title
Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 14, 2007 (Actual)
Primary Completion Date
September 8, 2011 (Actual)
Study Completion Date
September 8, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Candidiasis, Candidemia, Invasive Candidiasis, Esophageal Candidiasis
Keywords
Antifungal, Micafungin, Echinocandin, Candidiasis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Micafungin 3.0 mg
Arm Type
Experimental
Arm Description
IV
Arm Title
2. Micafungin 4.5 mg
Arm Type
Experimental
Arm Description
IV
Intervention Type
Drug
Intervention Name(s)
Micafungin
Other Intervention Name(s)
FK463
Intervention Description
IV
Primary Outcome Measure Information:
Title
PK parameters (AUCtau, Tmax, and Cmax)
Time Frame
10 - 14 Days
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
Day 1 to End of Study
Title
Vital signs
Time Frame
Day 1 to End of Study
Title
Hematology and chemistry laboratory tests
Time Frame
Day 1 to End of Study
Title
12-lead ECGs and Physical examination
Time Frame
Day 1 to End of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
University of California Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Benmed Park Clinic
City
Benoni
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Grootte Schuur Hospital
City
Cape Town
ZIP/Postal Code
7924
Country
South Africa
Facility Name
GCT -Sunnyside Medi-clinic
City
Lynn East
ZIP/Postal Code
0039
Country
South Africa
Facility Name
St. Mary's Hospital
City
Mariannhill
ZIP/Postal Code
3610
Country
South Africa
Facility Name
Jubilee Hospital
City
Temba
ZIP/Postal Code
0400
Country
South Africa
Facility Name
2 Military Hospital
City
Wynberg
ZIP/Postal Code
7824
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=260
Description
Link to results on the Astellas Clinical Study Results website

Learn more about this trial

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

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