Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
NCT ID: NCT00608335
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2007-10-14
2011-09-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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1. Micafungin 3.0 mg
IV
Micafungin
IV
2. Micafungin 4.5 mg
IV
Micafungin
IV
Interventions
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Micafungin
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
2 Years
16 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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University of California Los Angeles Medical Center
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
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
University of Texas Southwestern
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Benmed Park Clinic
Benoni, , South Africa
Grootte Schuur Hospital
Cape Town, , South Africa
GCT -Sunnyside Medi-clinic
Lynn East, , South Africa
St. Mary's Hospital
Mariannhill, , South Africa
Jubilee Hospital
Themba, , South Africa
2 Military Hospital
Wynberg, , South Africa
Countries
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Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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9463-CL-2101
Identifier Type: -
Identifier Source: org_study_id
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