Anidulafungin PK in Infants and Toddlers
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Anidulafungin PK in Infants and Toddlers|
- The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. [ Time Frame: 5 days ] [ Designated as safety issue: No ]Area under the curve at steady state
- Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. [ Time Frame: During and up to 10 days after last dose of study drug. ] [ Designated as safety issue: Yes ]Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.
|Study Start Date:||January 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.
Other Name: Eraxis
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734500
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|