Candidemia, Esophageal Candidiasis, Invasive Candidiasis, Oropharyngeal Candidiasis
Conditions
Keywords
Antifungal, Micafungin, Echinocandin, Candidiasis
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.
Interventions
DRUGMicafungin
IV
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters (AUCtau, Tmax, and Cmax) | 10 - 14 Days |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | Day 1 to End of Study |
| Vital signs | Day 1 to End of Study |
| Hematology and chemistry laboratory tests | Day 1 to End of Study |
| 12-lead ECGs and Physical examination | Day 1 to End of Study |
Countries
South Africa, United States
Outcome results
None listed