Caspofungin Study for Fungal Infections in Adults in Critical Care Settings
A Randomized, Double-Masked Trial of Caspofungin Versus Placebo as Prophylaxis of Invasive Candidiasis in High-Risk Adults in the Critical Care Setting
2 other identifiers
interventional
1,200
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2004
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 2, 2004
CompletedFirst Posted
Study publicly available on registry
November 3, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedDecember 5, 2014
June 1, 2006
November 2, 2004
December 4, 2014
Conditions
Keywords
Study Arms (2)
Placebo
PLACEBO COMPARATORSubjects receive placebo intravenously daily for 28 days
Caspofungin
EXPERIMENTALSubjects receive 50mg/day caspofungin intravenously (IV) for 28 days
Interventions
Caspofungin is an antifungal agent of the echinocandin class of glucan synthase inhibitor. Subjects receive Caspofungin acetate 50mg/day IV for 28 days.
Normal saline equivalent to that used to deliver the caspofungin given intravenously as a single daily dose infused over approximately 1 hour for 28 days
Eligibility Criteria
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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
University of Alabama Hospital - Infectious Diseases
Birmingham, Alabama, 35249-0001, United States
University of Southern California - Infectious Diseases
Los Angeles, California, 90089-0121, United States
Harbor UCLA Medical Center - Medicine - Infectious Diseases
Torrance, California, 90502-2006, United States
University of Colorado Hospital - Denver
Denver, Colorado, 80220-3706, United States
MedStar Washington Hospital Center - Infectious Diseases
Washington D.C., District of Columbia, 20010-3017, United States
Jackson Memorial Hospital
Miami, Florida, 33136-1005, United States
Emory University School of Medicine - Infectious Diseases
Atlanta, Georgia, 30303-3033, United States
Rush University Medical Center
Chicago, Illinois, 60612-3808, United States
University of Illinois at Chicago College of Medicine - Infectious Diseases
Chicago, Illinois, 60612-7300, United States
The University of Chicago - Medicine - Infectious Diseases & Global Health
Chicago, Illinois, 60637-1447, United States
Loyola University - Emergency Facility
Maywood, Illinois, 60153-3328, United States
Infectious Disease of Indiana, PSC
Indianapolis, Indiana, 46260-1992, United States
University of Kentucky - UK Albert B Chandler Hospital
Lexington, Kentucky, 40536-0001, United States
Overton Brooks VA Medical Center
Shreveport, Louisiana, 71101-4243, United States
Mark Hatfield Clinical Research Center
Bethesda, Maryland, 20892-0001, United States
Tufts Medical Center - Infectious Diseases Clinic
Boston, Massachusetts, 02111-1552, United States
University of Michigan - VA Ann Arbor Health Care Systems
Ann Arbor, Michigan, 48105-2303, United States
Harper University Hospital
Detroit, Michigan, 48201-2018, United States
Henry Ford Health System - Henry Ford Hospital
Detroit, Michigan, 48202-2608, United States
University of Mississippi - Infectious Diseases
Jackson, Mississippi, 39216-4505, United States
Cooper University Hospital - Infectious Diseases
Camden, New Jersey, 08103-1505, United States
Duke University Medical Center - Duke Clinical Research Institute
Durham, North Carolina, 27705-3824, United States
Memorial Hermann Hospital
Houston, Texas, 77030-1501, United States
University of Texas Health Science Center at San Antonio - Infectious Diseases
San Antonio, Texas, 78229-3901, United States
University of Virginia Primary Health Center - Infectious Diseases and International Health
Charlottesville, Virginia, 22908-1340, United States
University of Wisconsin Hospital and Clinics - Clinical Science Center - Nephrology
Madison, Wisconsin, 53792-0001, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 2004
First Posted
November 3, 2004
Study Start
October 1, 2004
Study Completion
September 1, 2006
Last Updated
December 5, 2014
Record last verified: 2006-06