Status:
COMPLETED
Anidulafungin PK in Infants and Toddlers
Lead Sponsor:
Michael Cohen-Wolkowiez
Conditions:
Invasive Fungal Infections
Eligibility:
All Genders
48-24 years
Phase:
PHASE1
Brief 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 sub...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00734500
Start Date
January 1 2008
End Date
June 1 2010
Last Update
November 21 2012
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27705