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Caspofungin Study for Fungal Infections in Adults in Critical Care Settings

Candidiasis Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00095316
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Terminated
Phase Phase 3
Start date October 2004
Completion date September 2006
View Details
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