Caspofungin Study for Fungal Infections in Adults in Critical Care Settings

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Candidiasis

In brief

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.

Key facts

Study ID

NCT00095316

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1200

Starts

2004-10-01

Expected to finish

2006-09-01

Last updated by the study team

2014-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 .

Where it is running

• University of Alabama Hospital - Infectious Diseases — Birmingham, Alabama, United States
• University of Southern California - Infectious Diseases — Los Angeles, California, United States
• Harbor UCLA Medical Center - Medicine - Infectious Diseases — Torrance, California, United States
• University of Colorado Hospital - Denver — Denver, Colorado, United States
• MedStar Washington Hospital Center - Infectious Diseases — Washington D.C., District of Columbia, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• Emory University School of Medicine - Infectious Diseases — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Illinois at Chicago College of Medicine - Infectious Diseases — Chicago, Illinois, United States
• The University of Chicago - Medicine - Infectious Diseases & Global Health — Chicago, Illinois, United States
• Loyola University - Emergency Facility — Maywood, Illinois, United States
• Infectious Disease of Indiana, PSC — Indianapolis, Indiana, United States
• University of Kentucky - UK Albert B Chandler Hospital — Lexington, Kentucky, United States
• Overton Brooks VA Medical Center — Shreveport, Louisiana, United States
• Mark Hatfield Clinical Research Center — Bethesda, Maryland, United States
• Tufts Medical Center - Infectious Diseases Clinic — Boston, Massachusetts, United States
• University of Michigan - VA Ann Arbor Health Care Systems — Ann Arbor, Michigan, United States
• Harper University Hospital — Detroit, Michigan, United States
• Henry Ford Health System - Henry Ford Hospital — Detroit, Michigan, United States
• University of Mississippi - Infectious Diseases — Jackson, Mississippi, United States
• Cooper University Hospital - Infectious Diseases — Camden, New Jersey, United States
• Duke University Medical Center - Duke Clinical Research Institute — Durham, North Carolina, United States
• Memorial Hermann Hospital — Houston, Texas, United States
• University of Texas Health Science Center at San Antonio - Infectious Diseases — San Antonio, Texas, United States
• University of Virginia Primary Health Center - Infectious Diseases and International Health — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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