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

Primary Purpose

Invasive Candidiasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Caspofungin
Normal Saline
Sponsored by
Mycoses Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Invasive Candidiasis focused on measuring Candida, Prophylaxis, High risk adults, Intensive care unit (ICU)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Southern California
  • University of Colorado
  • Washington Hospital Center
  • Tulane University
  • Harper University Hospital/ Wayne State
  • Henry Ford Hospital
  • St. Patrick's Hospital
  • Cooper University Hospital
  • The Ohio State University
  • University of Pennsylvania
  • Medical Center of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1 prophylaxis

2 placebo

Arm Description

Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy

Normal Saline 100 cc IV daily

Outcomes

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.
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.
All Cause Mortality
Initiation of Other Antifungals
Time to Development of Proven or Probable Invasive Candidiasis
Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.
Time to Beta Glucan Negativity in Pre-emptive Phase.
Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.
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.
Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event
Subjects With 1 or More Serious Drug-related Adverse Event(s)

Full Information

First Posted
August 21, 2007
Last Updated
April 8, 2011
Sponsor
Mycoses Study Group
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00520234
Brief Title
Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)
Acronym
MSG-01
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mycoses Study Group
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Candidiasis
Keywords
Candida, Prophylaxis, High risk adults, Intensive care unit (ICU)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 prophylaxis
Arm Type
Active Comparator
Arm Description
Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy
Arm Title
2 placebo
Arm Type
Placebo Comparator
Arm Description
Normal Saline 100 cc IV daily
Intervention Type
Drug
Intervention Name(s)
Caspofungin
Intervention Description
50 mg IV daily
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
placebo
Intervention Description
100 cc IV daily
Primary Outcome Measure Information:
Title
Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.
Description
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.
Time Frame
Within 7 days after end of therapy
Secondary Outcome Measure Information:
Title
Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.
Time Frame
Within 7 days of end of therapy
Title
All Cause Mortality
Time Frame
Within 7 days of end of therapy
Title
Initiation of Other Antifungals
Time Frame
Within 7 days after end of therapy
Title
Time to Development of Proven or Probable Invasive Candidiasis
Time Frame
Within 7 days after end of therapy
Title
Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.
Time Frame
Within 7 days after end of therapy
Title
Time to Beta Glucan Negativity in Pre-emptive Phase.
Time Frame
Within 14 days after end of therapy
Title
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
Title
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
Title
Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event
Time Frame
Up to 14 days after end of therapy
Title
Subjects With 1 or More Serious Drug-related Adverse Event(s)
Time Frame
Up to 14 days after end of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Ostrosky-Zeichner, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter G Pappas, MD
Organizational Affiliation
Mycoses Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35124
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Harper University Hospital/ Wayne State
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. Patrick's Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical Center of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11923348
Citation
Diekema DJ, Messer SA, Brueggemann AB, Coffman SL, Doern GV, Herwaldt LA, Pfaller MA. Epidemiology of candidemia: 3-year results from the emerging infections and the epidemiology of Iowa organisms study. J Clin Microbiol. 2002 Apr;40(4):1298-302. doi: 10.1128/JCM.40.4.1298-1302.2002.
Results Reference
background
PubMed Identifier
7548503
Citation
Jarvis WR. Epidemiology of nosocomial fungal infections, with emphasis on Candida species. Clin Infect Dis. 1995 Jun;20(6):1526-30. doi: 10.1093/clinids/20.6.1526.
Results Reference
background
PubMed Identifier
1542320
Citation
Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. doi: 10.1056/NEJM199203263261301.
Results Reference
background
PubMed Identifier
12039879
Citation
Denning DW. Echinocandins: a new class of antifungal. J Antimicrob Chemother. 2002 Jun;49(6):889-91. doi: 10.1093/jac/dkf045. No abstract available.
Results Reference
background
PubMed Identifier
24550378
Citation
Ostrosky-Zeichner L, Shoham S, Vazquez J, Reboli A, Betts R, Barron MA, Schuster M, Judson MA, Revankar SG, Caeiro JP, Mangino JE, Mushatt D, Bedimo R, Freifeld A, Nguyen MH, Kauffman CA, Dismukes WE, Westfall AO, Deerman JB, Wood C, Sobel JD, Pappas PG. MSG-01: A randomized, double-blind, placebo-controlled trial of caspofungin prophylaxis followed by preemptive therapy for invasive candidiasis in high-risk adults in the critical care setting. Clin Infect Dis. 2014 May;58(9):1219-26. doi: 10.1093/cid/ciu074. Epub 2014 Feb 18.
Results Reference
derived

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

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