Caspofungin Study for Fungal Infections in Adults in Critical Care Settings

NCT ID: NCT00095316

Last Updated: 2014-12-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2006-09-30

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.

Conditions

Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Subjects receive placebo intravenously daily for 28 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Caspofungin

Subjects receive 50mg/day caspofungin intravenously (IV) for 28 days

Group Type: EXPERIMENTAL

Caspofungin

Intervention Type: DRUG

Caspofungin is an antifungal agent of the echinocandin class of glucan synthase inhibitor. Subjects receive Caspofungin acetate 50mg/day IV for 28 days.

Interventions

Caspofungin

Caspofungin is an antifungal agent of the echinocandin class of glucan synthase inhibitor. Subjects receive Caspofungin acetate 50mg/day IV for 28 days.

Intervention Type: DRUG

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

Intervention Type: OTHER

Eligibility 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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Locations

University of Alabama Hospital - Infectious Diseases

Birmingham, Alabama, United States

University of Southern California - Infectious Diseases

Los Angeles, California, United States

Harbor UCLA Medical Center - Medicine - Infectious Diseases

Torrance, California, United States

University of Colorado Hospital - Denver

Denver, Colorado, United States

MedStar Washington Hospital Center - Infectious Diseases

Washington D.C., District of Columbia, United States

Jackson Memorial Hospital

Miami, Florida, 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

The University of Chicago - Medicine - Infectious Diseases & Global Health

Chicago, Illinois, United States

Loyola University - Emergency Facility

Maywood, Illinois, United States

Infectious Disease of Indiana, PSC

Indianapolis, Indiana, United States

University of Kentucky - UK Albert B Chandler Hospital

Lexington, Kentucky, United States

Overton Brooks VA Medical Center

Shreveport, Louisiana, United States

Mark Hatfield Clinical Research Center

Bethesda, Maryland, United States

Tufts Medical Center - Infectious Diseases Clinic

Boston, Massachusetts, United States

University of Michigan - VA Ann Arbor Health Care Systems

Ann Arbor, Michigan, United States

Harper University Hospital

Detroit, Michigan, United States

Henry Ford Health System - Henry Ford Hospital

Detroit, Michigan, United States

University of Mississippi - Infectious Diseases

Jackson, Mississippi, United States

Cooper University Hospital - Infectious Diseases

Camden, New Jersey, United States

Duke University Medical Center - Duke Clinical Research Institute

Durham, North Carolina, United States

Memorial Hermann Hospital

Houston, Texas, 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

Countries

United States

Other Identifiers

BAMSG 2-01

Identifier Type: -

Identifier Source: secondary_id

02-042

Identifier Type: -

Identifier Source: org_study_id