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

Study Overview
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Brief Summary
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Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed

Detailed Description
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This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment) at a daily dose of 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood samples for assessment of pharmacokinetics will be collected.

Official Title
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A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis

Conditions
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Invasive Candidiasis, Esophageal Candidiasis, Oropharyngeal Candidiasis, Candidemia

Intervention / Treatment
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* Drug: Micafungin (Mycamine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥4 months to < 24 months 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

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Micafungin<br> | Drug: Micafungin (Mycamine)<br>* IV<br>* Other names: FK463;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Micafungin pharmacokinetics |  | 10 - 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation |  | Day 1 to End of Study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antifungal, Echinocandin, Candidiasis, Micafungin