Status:
TERMINATED
Caspofungin Study for Fungal Infections in Adults in Critical Care Settings
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Candidiasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Candi...
Detailed 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...
Eligibility Criteria
Inclusion
- Non-pregnant subjects \>/= 18 years of age; admission to the ICU during the preceding 3 days (minimum of 2 days in ICU) and expected to stay in the ICU a minimum of 2 additional days; subjects must have at least 1 of the following: received at least one other dose of any systemic antibiotic on any one of the ICU days before study entry and continue to receive antibiotics at the time of enrollment, and/or presence of a central venous catheter at the time of enrollment and for one additional day during the current ICU stay, and at least 2 of the following: use of total parenteral nutrition on any of Days 1-4 of ICU stay; any type of dialysis on any of Days 1-4 of ICU stay; any in-patient surgery done under general anesthesia or epidural block in the 7 days prior to or on ICU admission\*; pancreatitis (documented by computed tomography (CT) scan or lipase \>1,000 u/L) in the 7 days prior to or on ICU admission; more than 1 dose of systemic steroids (prednisone equivalent dose \>/=20 mg per dose) in the 7 days prior to or on ICU admission; and/or use of more than 1 dose of other systemic immunosuppressive agents (such as azathioprine, tacrolimus, sirolimus, mycophenolate, monoclonal antibodies, and tumor necrosis factor \[TNF\] immunomodulators) in the 7 days prior to or on ICU admission.
- Excludes placement of vascular catheters.
Exclusion
- Subjects with an allergy or intolerance to caspofungin or other echinocandin analog; absolute neutrophil count \<500/mm3 at entry or likely to develop such a count during therapy; diagnosis of HIV, aplastic anemia, or chronic granulomatous disease; moderate or severe hepatic insufficiency as defined by a Child Pugh score of 7 or greater or cirrhosis due to any cause; pregnancy or breastfeeding; subjects unlikely to survive more than 2 days; subjects who have received systemic antifungal therapy within 7 days prior to study entry; subjects with documented active, proven, or probable invasive fungal infection within 7 days prior to study entry; subjects previously enrolled into this trial; subjects currently receiving another investigational agent or who have received an investigational agent within the 7 days prior to study entry; subjects in the ICU 5 or more days prior to enrollment into this study .
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2006
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00095316
Start Date
October 1 2004
End Date
September 1 2006
Last Update
December 5 2014
Active Locations (26)
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1
University of Alabama Hospital - Infectious Diseases
Birmingham, Alabama, United States, 35249-0001
2
University of Southern California - Infectious Diseases
Los Angeles, California, United States, 90089-0121
3
Harbor UCLA Medical Center - Medicine - Infectious Diseases
Torrance, California, United States, 90502-2006
4
University of Colorado Hospital - Denver
Denver, Colorado, United States, 80220-3706