Anidulafungin PK in Infants and Toddlers

Michael Cohen-Wolkowiez15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Invasive Fungal Infections

Interventions

AnidulafunginDRUG

Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.

Eligibility

Sex: ALLMin age: 48 HoursMax age: 24 Months

Medical Language ↔ Plain English

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.

Locations (1)

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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