Anidulafungin Versus Fluconazole in the Treatment of Candidemia
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.
|Study Design:||Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
|Official Title:||A Phase III, Double Blind, Randomized, Multi-Center Study of the Safety and Efficacy of Anidulafungin VS. Fluconazole in the Treatment of Patients With Candidemia and Other Forms of Invasive Candidiasis and Prevention of Complications|
|Study Start Date:||April 2003|
|Estimated Study Completion Date:||January 2005|
This study is designed as a prospective, randomized, double-blind, non-inferiority, multi-center trial of the safety and efficacy of anidulafungin versus fluconazole in patients with candidemia or other forms of invasive candidiasis. The objective of this study is to determine if anidulafungin is at least as effective as fluconazole in the treatment of patients with a diagnosis of candidemia and/or other forms of invasive candidiasis. The secondary objectives are to compare the safety of the two study drugs and determine the efficacy for the prevention of late Candida infections in patients treated with anidulafungin versus fluconazole. Assuming 25% of patients will be unevaluable at the end of intravenous therapy, 248 patients will be enrolled to obtain a total of 222 evaluable patients. Patients older than 16 years of age with candidemia or invasive candidiasis will be randomized to receive either anidulafungin or fluconazole. Patients randomized to anidulafungin will receive an IV loading dose on day one of 200mg followed by 100mg once daily. Patients randomized to fluconazole will receive an IV loading dose on day one of 800mg followed by an IV daily dose of 400mg. Patients will be maintained on IV therapy for a minimum of 10 days to a maximum of 42 days. After 10 days of therapy, patients on either study drug may be treated on an ambulatory basis with oral fluconazole therapy.
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|