Caspofungin Study for Fungal Infections in Adults in Critical Care Settings

Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00095316
• Other study ID #: 02-042
• Secondary ID: BAMSG 2-01
• Status: Terminated
• Phase: Phase 3
• First received: November 2, 2004
• Last updated: December 4, 2014
• Start date: October 2004
• Est. completion date: September 2006

Study information

• Verified date: June 2006
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1200
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 .

Study Design

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

Related Conditions & MeSH terms

• Candidiasis

Intervention

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.

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

Locations

Country	Name	City	State
United States	University of Michigan - VA Ann Arbor Health Care Systems	Ann Arbor	Michigan
United States	Emory University School of Medicine - Infectious Diseases	Atlanta	Georgia
United States	Mark Hatfield Clinical Research Center	Bethesda	Maryland
United States	University of Alabama Hospital - Infectious Diseases	Birmingham	Alabama
United States	Tufts Medical Center - Infectious Diseases Clinic	Boston	Massachusetts
United States	Cooper University Hospital - Infectious Diseases	Camden	New Jersey
United States	University of Virginia Primary Health Center - Infectious Diseases and International Health	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	The University of Chicago - Medicine - Infectious Diseases & Global Health	Chicago	Illinois
United States	University of Illinois at Chicago College of Medicine - Infectious Diseases	Chicago	Illinois
United States	University of Colorado Hospital - Denver	Denver	Colorado
United States	Harper University Hospital	Detroit	Michigan
United States	Henry Ford Health System - Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center - Duke Clinical Research Institute	Durham	North Carolina
United States	Memorial Hermann Hospital	Houston	Texas
United States	Infectious Disease of Indiana, PSC	Indianapolis	Indiana
United States	University of Mississippi - Infectious Diseases	Jackson	Mississippi
United States	University of Kentucky - UK Albert B Chandler Hospital	Lexington	Kentucky
United States	University of Southern California - Infectious Diseases	Los Angeles	California
United States	University of Wisconsin Hospital and Clinics - Clinical Science Center - Nephrology	Madison	Wisconsin
United States	Loyola University - Emergency Facility	Maywood	Illinois
United States	Jackson Memorial Hospital	Miami	Florida
United States	University of Texas Health Science Center at San Antonio - Infectious Diseases	San Antonio	Texas
United States	Overton Brooks VA Medical Center	Shreveport	Louisiana
United States	Harbor UCLA Medical Center - Medicine - Infectious Diseases	Torrance	California
United States	MedStar Washington Hospital Center - Infectious Diseases	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,