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.
- Age < 24 months at the time of enrollment
- Patient must have sufficient venous access to permit administration of study
- 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.
- 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.