Caspofungin Study for Fungal Infections in Adults in Critical Care Settings

A Randomized, Double-Masked Trial of Caspofungin Versus Placebo as Prophylaxis of Invasive Candidiasis in High-Risk Adults in the Critical Care Setting

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.

Study Overview

• Status: Terminated
• Conditions: Candidiasis
• Intervention / Treatment: Other: Placebo; Drug: Caspofungin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Study Completion: September 1, 2006

Study Registration Dates

• First Submitted: November 2, 2004
• First Submitted That Met QC Criteria: November 2, 2004
• First Posted (Estimate): November 3, 2004

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: June 1, 2006

More Information

Terms related to this study

• Keywords: candidiasis, caspofungin, fungal infection, prophylaxis
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Candidiasis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Caspofungin
• Other Study ID Numbers: 02-042; BAMSG 2-01