Clinical trial NCT00095316: Caspofungin Study for Fungal Infections in Adults in Critical Care Settings
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Candidiasis
Keywords: candidiasis, caspofungin, fungal infection, prophylaxis
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2004-11-03
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 .

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