Anidulafungin PK in Infants and Toddlers
Information source: Duke University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Invasive Fungal Infections
Intervention: Anidulafungin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Michael Cohen-Wolkowiez
Summary
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.
Clinical Details
Official title: Anidulafungin PK in Infants and Toddlers
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Secondary outcome: Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Eligibility
Minimum age: N/A.
Maximum age: 24 Months.
Gender(s): Both.
Criteria:
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 and Contacts
Duke University, Durham, North Carolina 27705, United States
Additional Information
Starting date: January 2008
Last updated: November 16, 2012
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