Caspofungin Study for Fungal Infections in Adults in Critical Care Settings

Condition(s) targeted: Candidiasis

Intervention: Caspofungin (Drug); Placebo (Other)

Phase: Phase 3

Status: Terminated

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 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 Criteria: 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 .

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, 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

The University of Chicago - Medicine - Infectious Diseases & Global Health, Chicago, Illinois 60637-1447, United States

University of Illinois at Chicago College of Medicine - Infectious Diseases, Chicago, Illinois 60612-7300, 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

Starting date: October 2004
Last updated: December 4, 2014