Invasive Fungal Infections
Conditions
Brief summary
This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.
Interventions
DRUGAnidulafungin
Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.
Sponsors
Michael Cohen-Wolkowiez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
48 Hours to 24 Months
Healthy volunteers
No
Inclusion criteria
* Age \< 24 months at the time of enrollment * Patient must have sufficient venous access to permit administration of study medication * Infant or toddler suspected to have a serious infection and from whom a blood culture has been obtained with 48 hours of study entry * Availability and willingness of the parent/legally authorized representative to provide written informed consent.
Exclusion criteria
* Patients with a history of anaphylaxis attributed to an echinocandin * Any other concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study * Previous participation in this study * Previous exposure to an echinocandin in the month prior to study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. | 5 days | Area under the curve at steady state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. | During and up to 10 days after last dose of study drug. | Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anidulafungin Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day) | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Anidulafungin |
|---|---|
| Age Continuous | 0.22 years STANDARD_DEVIATION 0.32 |
| Age, Customized <=24 months | 15 participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
Primary
The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Area under the curve at steady state
Time frame: 5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Anidulafungin | The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. | 84 µg*h/mL |
Secondary
Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.
Time frame: During and up to 10 days after last dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. | 8 participants |