Caspofungin Study for Fungal Infections in Adults in Critical Care Settings

This study has been terminated.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00095316
First received: November 2, 2004
Last updated: August 26, 2010
Last verified: June 2006
  Purpose

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.


Condition Intervention Phase
Candidiasis
Drug: Caspofungin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 1200
Study Start Date: October 2004
Estimated Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 .

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095316

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of Southern California
Los Angeles, California, United States, 90033
UCLA Center For Vaccine Research
Torrance, California, United States, 90509
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Miami
Miami, Florida, United States, 33136-1096
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 5065
Rush University Medical Center
Chicago, Illinois, United States, 60612
Loyola University
Maywood, Illinois, United States, 60153
United States, Indiana
Infectious Disease of Indiana, PSC
Indianapolis, Indiana, United States, 46260
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536-0298
United States, Louisiana
Louisiana State University
Shreveport, Louisiana, United States, 71101
United States, Maryland
Mark O. Hatfield Clinical Research Center
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Harper University Hospital
Detroit, Michigan, United States, 48201
United States, Mississippi
University of Mississippi
Jackson, Mississippi, United States, 39216
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
The University of Texas Health Science Center
San Antonio, Texas, United States, 78229-3900
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
University of Wisconsin Medical School
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00095316     History of Changes
Other Study ID Numbers: 02-042, BAMSG 2-01
Study First Received: November 2, 2004
Last Updated: August 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
candidiasis, caspofungin, fungal infection, intensive care unit, prophylaxis

Additional relevant MeSH terms:
Candidiasis
Mycoses
Candidiasis, Invasive
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014