Status:
COMPLETED
β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients
Lead Sponsor:
Duke University
Collaborating Sponsors:
Pfizer
Conditions:
Invasive Candidiasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Admission to the intensive care unit for ≥ 72 hours and expected to stay an additional 48 hours
- IV access for administration of study drug
- Subject (or subject's legal representative) able to give written informed consent
Exclusion
- History of hypersensitivity or intolerance to echinocandin antifungals
- Liver function test (ALT, AST (aspartate aminotransferase), and/or total bilirubin) greater than 10 times the upper limits of normal (ULN)
- Pregnant or lactating women
- Treatment with systemic antifungal therapy within the preceding 7 days
- Documented invasive fungal infection at baseline/screening
- Life expectancy less than 2 days or moribund
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00672841
Start Date
June 1 2008
End Date
January 1 2011
Last Update
February 6 2015
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710