Status:
COMPLETED
Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
Lead Sponsor:
Pfizer
Conditions:
Invasive Candidiasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.
Eligibility Criteria
Inclusion
- ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:
- Post-abdominal surgery.
- Elderly \> 65 years old.
- Renal insufficiency / failure / hemodialysis.
- Solid tumor.
- Solid-organ (liver, kidney, lung, heart) transplant recipients.
- Hepatic insufficiency.
- Neutropenic including hematology oncology patients.
Exclusion
- Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00689338
Start Date
July 1 2008
End Date
May 1 2010
Last Update
May 30 2011
Active Locations (61)
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1
Pfizer Investigational Site
Vienna, Austria, A-1090
2
Pfizer Investigational Site
Brussels, Belgium, 1090
3
Pfizer Investigational Site
Brussels, Belgium, B-1070
4
Pfizer Investigational Site
Ghent, Belgium, 9000