Study of Mycamine® in Infants and Toddlers 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 Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00607763

Enrollment

Registered

2008-02-06

Start date

2007-10-31

Completion date

2009-10-31

Last updated

2014-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidemia, Esophageal Candidiasis, Invasive Candidiasis, Oropharyngeal Candidiasis

Keywords

Antifungal, Echinocandin, Candidiasis, Micafungin

Brief summary

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

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.

Interventions

DRUGMicafungin (Mycamine)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Months to 23 Months

Healthy volunteers

Inclusion criteria

1. Subject is ≥4 months to \< 24 months 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

Design outcomes

Primary

Measure	Time frame
Evaluation of Micafungin pharmacokinetics	10 - 14 Days

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026