Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)
NCT ID: NCT00520234
Last Updated: 2011-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
222 participants
INTERVENTIONAL
2007-08-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1 prophylaxis
Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy
Caspofungin
50 mg IV daily
2 placebo
Normal Saline 100 cc IV daily
Normal Saline
100 cc IV daily
Interventions
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Caspofungin
50 mg IV daily
Normal Saline
100 cc IV daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Mycoses Study Group
NETWORK
Responsible Party
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Merck
Principal Investigators
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Luis Ostrosky-Zeichner, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Peter G Pappas, MD
Role: PRINCIPAL_INVESTIGATOR
Mycoses Study Group
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
University of Colorado
Denver, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Tulane University
New Orleans, Louisiana, United States
Harper University Hospital/ Wayne State
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Patrick's Hospital
Missoula, Montana, United States
Cooper University Hospital
Camden, New Jersey, United States
The Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical Center of South Carolina
Charleston, South Carolina, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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MSG-01
Identifier Type: -
Identifier Source: org_study_id
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