Status:
TERMINATED
An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System
Lead Sponsor:
Pfizer
Conditions:
Fungemia
Neutropenia
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will...
Eligibility Criteria
Inclusion
- Dysfunctional immune system (reduced neutrophils).
- Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection.
- Male of female ≥16 years of age.
- Expected hospitalization for at least ten (10) days.
Exclusion
- Pregnancy or breast feeding or planning to become pregnant during the study.
- Recent treatment with one of the study drugs over the last 30 days.
- Allergy to either study drug or to this class of drugs.
- Significant liver dysfunction.
- Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00806351
Start Date
August 1 2009
End Date
October 1 2011
Last Update
December 20 2012
Active Locations (10)
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1
Pfizer Investigational Site
Sarajevo, Bosnia and Herzegovina, 71000
2
Pfizer Investigational Site
Grenoble, France, 38043
3
Pfizer Investigational Site
Strasbourg, France, 67098
4
Pfizer Investigational Site
Bologna, Italy, 40138