Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU) (MSG-01)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Mycoses Study Group
ClinicalTrials.gov Identifier:
NCT00520234
First received: August 21, 2007
Last updated: April 8, 2011
Last verified: April 2011
  Purpose

Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.


Condition Intervention Phase
Invasive Candidiasis
Drug: Caspofungin
Drug: Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo Controlled Trial of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in High-risk Adults in the Critical Care Setting

Resource links provided by NLM:


Further study details as provided by Mycoses Study Group:

Primary Outcome Measures:
  • Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria. [ Time Frame: Within 7 days after end of therapy ] [ Designated as safety issue: No ]
    Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.


Secondary Outcome Measures:
  • Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria. [ Time Frame: Within 7 days of end of therapy ] [ Designated as safety issue: No ]
  • All Cause Mortality [ Time Frame: Within 7 days of end of therapy ] [ Designated as safety issue: No ]
  • Initiation of Other Antifungals [ Time Frame: Within 7 days after end of therapy ] [ Designated as safety issue: No ]
  • Time to Development of Proven or Probable Invasive Candidiasis [ Time Frame: Within 7 days after end of therapy ] [ Designated as safety issue: No ]
  • Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis. [ Time Frame: Within 7 days after end of therapy ] [ Designated as safety issue: No ]
  • Time to Beta Glucan Negativity in Pre-emptive Phase. [ Time Frame: Within 14 days after end of therapy ] [ Designated as safety issue: No ]
  • Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase. [ Time Frame: Within 14 days after end of therapy ] [ Designated as safety issue: No ]
  • Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available. [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  • Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event [ Time Frame: Up to 14 days after end of therapy ] [ Designated as safety issue: Yes ]
  • Subjects With 1 or More Serious Drug-related Adverse Event(s) [ Time Frame: Up to 14 days after end of therapy ] [ Designated as safety issue: Yes ]

Enrollment: 222
Study Start Date: August 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 prophylaxis
Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy
Drug: Caspofungin
50 mg IV daily
Other Name: caspofungin
Placebo Comparator: 2 placebo
Normal Saline 100 cc IV daily
Drug: Normal Saline
100 cc IV daily
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-pregnant >18 yrs of age
  • Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.
  • Subjects meeting the clinical prediction rule

Exclusion Criteria:

  • Subjects with an allergy/intolerance to caspofungin or echinocandin analog
  • absolute neutrophil count <500/mm3 at study entry or likely to develop such a count during therapy
  • acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease
  • moderate or severe hepatic insufficiency
  • subjects who are pregnant or lactating
  • unlikely to survive < 24 hours
  • subjects who have received systemic antifungal therapy within 10 days prior to study entry
  • Documented active proven or probable invasive fungal infection upon enrollment
  • previously enrolled in this study
  • Currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.
  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: NCT00520234

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35124
United States, California
University of Southern California
Los Angeles, California, United States, 29425
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Michigan
Harper University Hospital/ Wayne State
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Montana
St. Patrick's Hospital
Missoula, Montana, United States, 59802
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical Center of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Mycoses Study Group
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Luis Ostrosky-Zeichner, MD The University of Texas Health Science Center, Houston
Principal Investigator: Peter G Pappas, MD Mycoses Study Group
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00520234     History of Changes
Other Study ID Numbers: MSG-01
Study First Received: August 21, 2007
Results First Received: March 15, 2011
Last Updated: April 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mycoses Study Group:
Candida
Prophylaxis
High risk adults
Intensive care unit (ICU)

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

ClinicalTrials.gov processed this record on November 20, 2014