Anidulafungin PK in Infants and Toddlers

Completed · Phase 1

Conditions studied: Invasive Fungal Infections

In brief

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.

Key facts

Study ID

NCT00734500

Run by

Michael Cohen-Wolkowiez

People needed

15

Starts

2008-01-01

Expected to finish

2010-06-01

Last updated by the study team

2012-11-21

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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