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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: December 4, 2014
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
Other: Placebo
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
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects receive placebo intravenously daily for 28 days
Other: Placebo
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
Experimental: Caspofungin
Subjects receive 50mg/day caspofungin intravenously (IV) for 28 days
Drug: Caspofungin
Caspofungin is an antifungal agent of the echinocandin class of glucan synthase inhibitor. Subjects receive Caspofungin acetate 50mg/day IV for 28 days.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Hospital - Infectious Diseases
Birmingham, Alabama, United States, 35249-0001
United States, California
University of Southern California - Infectious Diseases
Los Angeles, California, United States, 90089-0121
Harbor UCLA Medical Center - Medicine - Infectious Diseases
Torrance, California, United States, 90502-2006
United States, Colorado
University of Colorado Hospital - Denver
Denver, Colorado, United States, 80220-3706
United States, District of Columbia
MedStar Washington Hospital Center - Infectious Diseases
Washington, District of Columbia, United States, 20010-3017
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136-1005
United States, Georgia
Emory University School of Medicine - Infectious Diseases
Atlanta, Georgia, United States, 30303-3033
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612-3808
The University of Chicago - Medicine - Infectious Diseases & Global Health
Chicago, Illinois, United States, 60637-1447
University of Illinois at Chicago College of Medicine - Infectious Diseases
Chicago, Illinois, United States, 60612-7300
Loyola University - Emergency Facility
Maywood, Illinois, United States, 60153-3328
United States, Indiana
Infectious Disease of Indiana, PSC
Indianapolis, Indiana, United States, 46260-1992
United States, Kentucky
University of Kentucky - UK Albert B Chandler Hospital
Lexington, Kentucky, United States, 40536-0001
United States, Louisiana
Overton Brooks VA Medical Center
Shreveport, Louisiana, United States, 71101-4243
United States, Maryland
Mark Hatfield Clinical Research Center
Bethesda, Maryland, United States, 20892-0001
United States, Massachusetts
Tufts Medical Center - Infectious Diseases Clinic
Boston, Massachusetts, United States, 02111-1552
United States, Michigan
University of Michigan - VA Ann Arbor Health Care Systems
Ann Arbor, Michigan, United States, 48105-2303
Harper University Hospital
Detroit, Michigan, United States, 48201-2018
Henry Ford Health System - Henry Ford Hospital
Detroit, Michigan, United States, 48202-2608
United States, Mississippi
University of Mississippi - Infectious Diseases
Jackson, Mississippi, United States, 39216-4505
United States, New Jersey
Cooper University Hospital - Infectious Diseases
Camden, New Jersey, United States, 08103-1505
United States, North Carolina
Duke University Medical Center - Duke Clinical Research Institute
Durham, North Carolina, United States, 27705-3824
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030-1501
University of Texas Health Science Center at San Antonio - Infectious Diseases
San Antonio, Texas, United States, 78229-3901
United States, Virginia
University of Virginia Primary Health Center - Infectious Diseases and International Health
Charlottesville, Virginia, United States, 22908-1340
United States, Wisconsin
University of Wisconsin Hospital and Clinics - Clinical Science Center - Nephrology
Madison, Wisconsin, United States, 53792-0001
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: December 4, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on February 27, 2015