Caspofungin Study for Fungal Infections in Adults in Critical Care Settings
Adults admitted to intensive care units are at risk for a variety of complications. One of the most frequent complications is the development of new infections. Infections due to a fungus called Candida are of particular concern. This study will test the possibility that caspofungin, a new therapy for fungal infections, may reduce the rate of Candida infections in subjects at risk.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Randomized, Double-Masked Trial of Caspofungin Versus Placebo as Prophylaxis of Invasive Candidiasis in High-Risk Adults in the Critical Care Setting|
|Study Start Date:||October 2004|
|Estimated Study Completion Date:||September 2006|
Placebo Comparator: Placebo
Subjects receive placebo intravenously daily for 28 days
Normal saline equivalent to that used to deliver the caspofungin given intravenously as a single daily dose infused over approximately 1 hour for 28 days
Subjects receive 50mg/day caspofungin intravenously (IV) for 28 days
Caspofungin is an antifungal agent of the echinocandin class of glucan synthase inhibitor. Subjects receive Caspofungin acetate 50mg/day IV for 28 days.
A Randomized, Double-Masked Trial of Caspofungin (50 mg/day) Versus Placebo as Prophylaxis of Invasive Candidiasis in HighRisk Adults in the Critical Care Setting for up to 28 days with observation of primary outcome through 7 days after study therapy. The primary objective of this study is to evaluate the efficacy of caspofungin as prophylaxis for invasive candidiasis in high-risk ICU patients as opposed to those receiving placebo whereas the secondary objectives are as follows: To evaluate the utility of surrogate markers for the diagnosis of invasive candidiasis, to assess the effect of colonization as a risk factor in developing the disease, evaluate the safety of prophylactic caspofungin in subjects who discontinue the study due to drug-related adverse events versus subjects with 1 or more drug-related adverse events and to evaluate the all-cause mortality.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095316
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