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Durham, North Carolina 27705


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.


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.



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Durham, North Carolina 27705
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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