Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095316
Status:
TERMINATED
Last Update Posted:
2014-12-05
First Post:
2004-11-02
Brief Title:
Caspofungin Study for Fungal Infections in Adults in Critical Care Settings
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
A Randomized Double-Masked Trial of Caspofungin 50 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BAMSG 2-01 | None | None | None |