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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Micafungin 3.0 mg | Experimental | IV |
|
| 2. Micafungin 4.5 mg | Experimental | IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters (AUCtau, Tmax, and Cmax) | 10 - 14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Day 1 to End of Study | |
| Vital signs | Day 1 to End of Study | |
| Hematology and chemistry laboratory tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles Medical Center | Los Angeles | California | 90095 | United States | ||
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| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
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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/.
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.
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.
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| Day 1 to End of Study |
| 12-lead ECGs and Physical examination | Day 1 to End of Study |
| 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 |
| ID | Term |
|---|---|
| D058387 | Candidemia |
| D058365 | Candidiasis, Invasive |
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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