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

NCT00520234 | Completed Phase 4 Results DMC

• 1 other identifier: MSG-01
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 12

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.

Conditions

Invasive Candidiasis

Keywords

Candida; Prophylaxis; High risk adults; Intensive care unit (ICU)

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 7 days after end of therapy

Secondary Outcomes (10)

• Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.

  Within 7 days of end of therapy

• All Cause Mortality

  Within 7 days of end of therapy

• Initiation of Other Antifungals

  Within 7 days after end of therapy

• Time to Development of Proven or Probable Invasive Candidiasis

  Within 7 days after end of therapy

• Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.

  Within 7 days after end of therapy

Study Arms (2)

1 prophylaxis

ACTIVE COMPARATOR

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

Drug: Caspofungin

2 placebo

PLACEBO COMPARATOR

Normal Saline 100 cc IV daily

Drug: Normal Saline

Interventions

Caspofungin DRUG

50 mg IV daily

1 prophylaxis

Normal Saline DRUG

100 cc IV daily

Also known as: placebo

2 placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mycoses Study Group: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (12)

University of Alabama at Birmingham

Birmingham, Alabama, 35124, United States

Location

University of Southern California

Los Angeles, California, 29425, United States

Location

University of Colorado

Denver, Colorado, 80262, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Harper University Hospital/ Wayne State

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St. Patrick's Hospital

Missoula, Montana, 59802, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical Center of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (5)

• 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.

  PMID: 11923348 BACKGROUND

• 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.

  PMID: 7548503 BACKGROUND

• 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.

  PMID: 1542320 BACKGROUND

• 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.

  PMID: 12039879 BACKGROUND

• 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.

  PMID: 24550378 DERIVED

MeSH Terms

Conditions

Candidiasis, Invasive; Torulopsis

Interventions

Caspofungin; Saline Solution

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Luis Ostrosky-Zeichner, MD
• Organization: Mycoses Study Group

Luis.Ostrosky-Zeichner@uth.tmc.edu

(713) 500-6733

Study Officials

• Luis Ostrosky-Zeichner, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Peter G Pappas, MD

  Mycoses Study Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 21, 2007
• First Posted: August 23, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 9, 2011
• Results First Posted: May 9, 2011

Record last verified: 2011-04

Locations

US (12)