Caspofungin Study for Fungal Infections in Adults in Critical Care Settings
- Registration Number
- NCT00095316
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1200
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.
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 .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subjects receive placebo intravenously daily for 28 days Caspofungin Caspofungin Subjects receive 50mg/day caspofungin intravenously (IV) for 28 days
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Harbor UCLA Medical Center - Medicine - Infectious Diseases
🇺🇸Torrance, California, United States
Loyola University - Emergency Facility
🇺🇸Maywood, Illinois, United States
Cooper University Hospital - Infectious Diseases
🇺🇸Camden, New Jersey, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
University of Southern California - Infectious Diseases
🇺🇸Los Angeles, California, United States
Overton Brooks VA Medical Center
🇺🇸Shreveport, Louisiana, United States
The University of Chicago - Medicine - Infectious Diseases & Global Health
🇺🇸Chicago, Illinois, United States
MedStar Washington Hospital Center - Infectious Diseases
🇺🇸Washington, District of Columbia, 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
University of Mississippi - Infectious Diseases
🇺🇸Jackson, Mississippi, United States
Tufts Medical Center - Infectious Diseases Clinic
🇺🇸Boston, Massachusetts, United States
Mark Hatfield Clinical Research Center
🇺🇸Bethesda, Maryland, United States
University of Kentucky - UK Albert B Chandler Hospital
🇺🇸Lexington, Kentucky, United States
University of Alabama Hospital - Infectious Diseases
🇺🇸Birmingham, Alabama, United States
University of Colorado Hospital - Denver
🇺🇸Denver, Colorado, United States
University of Michigan - VA Ann Arbor Health Care Systems
🇺🇸Ann Arbor, Michigan, United States
Harper University Hospital
🇺🇸Detroit, Michigan, United States
Duke University Medical Center - Duke Clinical Research Institute
🇺🇸Durham, North Carolina, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Henry Ford Health System - Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Infectious Disease of Indiana, PSC
🇺🇸Indianapolis, Indiana, 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
University of Wisconsin Hospital and Clinics - Clinical Science Center - Nephrology
🇺🇸Madison, Wisconsin, United States