A Randomized Double-Masked Trial of Caspofungin Versus Placebo as Prophylaxis of Invasive Candidiasis in High-Risk Adults in the Critical Care Setting
This study is designed as a prospective, multi-center randomized double-masked
placebo-controlled trial of caspofungin versus placebo for prevention of invasive
candidiasis in high-risk adults in the critical care setting. The objective of this study
is to evaluate the efficacy of caspofungin as prophylaxis for invasive candidiasis in
high-risk ICU subjects by comparing the risk of invasive candidiasis in subjects receiving
caspofungin with the risk in those receiving placebo. The secondary objectives are to
evaluate the rate of invasive candidiasis in subjects meeting the clinical prediction rule;
to prospectively assess the effect of colonization as a risk factor for the development of
invasive candidiasis; to evaluate the safety of caspofungin as prophylaxis for invasive
candidiasis by summarizing the proportion of subjects who discontinue study therapy because
of a drug-related adverse event and the proportion of subjects with one or more drug-related
adverse event(s); and to evaluate all-cause mortality. The planned sample size will be 1200
subjects, 1/3 in the control arm and 2/3 in the active treatment arm based on a power of at
least 0.8 needed to detect a 50% reduction in incidence from base rate of 11% to 5.5%.
High-risk icu subjects greater than or equal to 18 years of age meeting all eligibility
criteria with at least 5 days of anticipated ICU stay will be randomized to receive either
caspofungin 50 mg/day (70 mg/day for subjects on rifampin) or placebo (normal saline) daily.
Caspofungin or placebo will be given intravenously as a single daily dose infused over
approximately one hour. Subjects will receive study drug or placebo for the duration on
their icu stay, up to a maximum of 28 days.
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
|National Cancer Institute (NCI)||Bethesda, Maryland 20892|