Anidulafungin Versus Fluconazole in the Treatment of Candidemia
Status:
Completed
Trial end date:
2005-01-01
Target enrollment:
Participant gender:
Summary
Fluconazole is an FDA-approved drug that is widely used to treat fungal infections due to
candida. The experimental drug anidulafungin has been found to be active in treating
life-threatening fungal infections. The purpose of this study is to determine whether
anidulafungin is as effective as fluconazole in treating candidemia, an invasive form of
candidiasis.
Three hundred patients 16 years of age or older will participate in this study. Participants
will be randomly assigned to one of two groups: one-half will receive anidulafungin; the
other half will receive fluconazole. They will receive the drug for as few as 10 days or for
up to 42 days, depending on the seriousness of the infection. The drug will be given over a
four-hour period on the first day, and over two hours on the remaining days. While taking the
study medication, participants will be required to give blood samples every week until the
end of treatment. At two weeks and six weeks following the end of therapy, participants will
return for evaluation.
Prior to their participation in this study, patients will undergo the following evaluations:
a physical exam, an eye exam, an electrocardiogram, and possibly blood work.