Candida
Conditions
Keywords
Micafungin, Candida, Neonates, Mycamine, FK463
Brief summary
This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection
Detailed description
Subjects will be stratified by weight to receive one of two doses of study drug
Interventions
DRUGMicafungin
IV Administration
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
48 Hours to 120 Days
Healthy volunteers
No
Inclusion criteria
* Informed consent and HIPAA authorization of the infant's parent or legally authorized representative must be obtained prior to study entry * Infant has sufficient venous access to permit study drug dosing * Infant is suspected to have a systemic Candida infection and appropriate cultures (blood with or without urine/CSF) are obtained at the time of study entry
Exclusion criteria
* Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals * Infant has received an echinocandin within one month prior to study entry * Infant has a concomitant medical condition which, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk * Infant has a life expectancy of less than 96 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of micafungin plasma pharmacokinetic parameters | Day 4 |
Secondary
| Measure | Time frame |
|---|---|
| Monitor adverse events | 11 or 12 Days |
Countries
United States
Outcome results
None listed