Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

NCT00105144 | Completed Phase 3

• 1 other identifier: 03-0-192
• Study Type: interventional
• Target: 611
• Locations: 15 countries
• Sites: 167

Brief Summary

The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.

Conditions

Candidiasis; Candidemia

Keywords

Treatment Effectiveness; Treatment Efficacy; Investigational, Therapies; Antifungal, Systemic; Antibiotics, Antifungal; Micafungin

Outcome Measures

Primary Outcomes (1)

• Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy

  End of therapy and 6 weeks post-treatment

Secondary Outcomes (1)

• Overall treatment success, based on the Data Review Panel's assessment of pre-defined clinical and mycological response at the End of IV Therapy

  End of therapy and 6 weeks post-treatment

Study Arms (3)

1

EXPERIMENTAL

lower dose

Drug: Micafungin

2

EXPERIMENTAL

higher dose

Drug: Micafungin

3

ACTIVE COMPARATOR

Drug: Caspofungin

Interventions

Micafungin DRUG

IV

Also known as: Mycamine, FK463

1; 2

Caspofungin DRUG

IV

Also known as: Cancidas

3

Eligibility Criteria

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

You may qualify if:

• Patients must have candidemia or invasive candidiasis.

You may not qualify if:

• Patients who have received an echinocandin within one month prior to study entry.
• Patients who have received more than two days of prior systemic antifungal therapy for the current infection.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (167)

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Birmingham, Alabama, 35294, United States

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Little Rock, Arkansas, 72205, United States

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90095, United States

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San Francisco, California, 94115, United States

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Denver, Colorado, 80204, United States

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Denver, Colorado, 80262, United States

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

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Bay Pines, Florida, 33744, United States

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Miami, Florida, 33136, United States

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Atlanta, Georgia, 30322, United States

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Augusta, Georgia, 30909, United States

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Augusta, Georgia, 30912, United States

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Chicago, Illinois, 60612, United States

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Chicago, Illinois, 60637, United States

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Maywood, Illinois, 60153, United States

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Beech Grove, Indiana, 46107, United States

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Evansville, Indiana, 47714, United States

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Des Moines, Iowa, 50309, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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Wichita, Kansas, 67214, United States

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Lexington, Kentucky, 40536, United States

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New Orleans, Louisiana, 70121, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02215, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55455, United States

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Jackson, Mississippi, 39216, United States

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St Louis, Missouri, 63310, United States

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Neptune City, New Jersey, 07754, United States

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Albany, New York, 12208, United States

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Manhasset, New York, 11030, United States

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New Hyde Park, New York, 11040, United States

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New York, New York, 10029, United States

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New York, New York, 10032, United States

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Rochester, New York, 14642, United States

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Stony Brook, New York, 11794, United States

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The Bronx, New York, 10467, United States

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Valhalla, New York, 10595, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27157, United States

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Cincinnati, Ohio, 45267, United States

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Columbus, Ohio, 43210, United States

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Allentown, Pennsylvania, 18103, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19140, United States

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Pittsburgh, Pennsylvania, 15213, United States

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West Reading, Pennsylvania, 19611, United States

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Providence, Rhode Island, 02908, United States

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Jackson, Tennessee, 38301, United States

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Memphis, Tennessee, 38104, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Charlottesville, Virginia, 22908, United States

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Fairfax, Virginia, 22030, United States

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Seattle, Washington, 98109, United States

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Vienna, 1090, Austria

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Aalst, 9300, Belgium

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Brussels, 1000, Belgium

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Liège, 4800, Belgium

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Belo Horizonte, Mg-cep, 30140-093, Brazil

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Belo Horizonte, Mg-cep, 30190-081, Brazil

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Belo Horizonte, Minas Gerais, 30190-081, Brazil

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Cunitiba, Pr-cep, 80060-900, Brazil

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Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Santos, São Paulo, 11045-904, Brazil

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São José do Rio Preto, São Paulo, 15090-000, Brazil

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São Paulo, São Paulo, 04039-020, Brazil

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Belo Horizonte, 30110-908, Brazil

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Belo Horizonte, 30130-110, Brazil

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Belo Horizonte, 30190-130, Brazil

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Salvador, 40050-410, Brazil

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Salvador, 40110-160, Brazil

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São Paulo, 01500-000, Brazil

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São Paulo, 04012-180, Brazil

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São Paulo, 04040-002, Brazil

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Edmonton, Alberta, T6G 2B7, Canada

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Kelowna, British Columbia, V1Y 1T2, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Hamilton, Ontario, L8V 1C3, Canada

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Kingston, Ontario, K7L 2V7, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 2N2, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H2X 2P4, Canada

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Québec, Quebec, G1R 2J6, Canada

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Regina, Saskatchewan, S4P 0W5, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Zagreb, 10000, Croatia

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Prague, 14021, Czechia

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Bobigny, 93009, France

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Metz, 57000, France

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Paris, 75181, France

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Paris, 75651, France

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Paris, 75674, France

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Paris, 75877, France

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Strasbourg, 67098, France

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Villejuif, 94084, France

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Villejuif, 94805, France

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Berlin, 10117, Germany

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Bielefeld, 33611, Germany

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Cologne, 50937, Germany

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Frankfurt, 60590, Germany

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Hanover, 30625, Germany

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Ulm, 89081, Germany

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Würzburg, 97070, Germany

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Bangalore, 560017, India

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Bangalore, 56017, India

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Bangalore, India

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Banglore, 560 054, India

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Chandigarh, India

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Chennai, 35, India

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Chennai, 600 006, India

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Cochin Kerala, 682 026, India

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Hyderabad, 500 009, India

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Hyderabad, 500 033, India

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Hyderabad, 500 034, India

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Hyderabad, 500 082, India

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Kochi, India

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Kolkotta, 700 029, India

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Lucknow, 226 014, India

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Ludhiana, 141 009, India

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Mangalore, 575 001, India

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Manipal, 576 104, India

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Mumbai, 400 012, India

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Mumbai, 400 026, India

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Uttar Pradesh, 201 301, India

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Groningen, 9700 RB, Netherlands

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Gdansk, 80-211, Poland

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Lodz, 93-513, Poland

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Warsaw, 00-957, Poland

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Barakaldo, 48903, Spain

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Barcelona, 08003, Spain

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Barcelona, 08025, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Madrid, 28005, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Salamanca, 37007, Spain

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Santander, 39008, Spain

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Seville, 41014, Spain

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Valencia, 46009, Spain

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Sankt Gallen, 9007, Switzerland

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London, England, SE1 7EH, United Kingdom

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London, England, SW10 9NH, United Kingdom

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London, England, W6 8RF, United Kingdom

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Manchester, England, M23 9LT, United Kingdom

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Glasgow, GB, G11 6NT, United Kingdom

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Leeds, GB, LS1 3EX, United Kingdom

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Leeds, GB, LS9 7TF, United Kingdom

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Related Publications (2)

• Pappas PG, Rotstein CM, Betts RF, Nucci M, Talwar D, De Waele JJ, Vazquez JA, Dupont BF, Horn DL, Ostrosky-Zeichner L, Reboli AC, Suh B, Digumarti R, Wu C, Kovanda LL, Arnold LJ, Buell DN. Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. Clin Infect Dis. 2007 Oct 1;45(7):883-93. doi: 10.1086/520980. Epub 2007 Aug 29.

  PMID: 17806055 BACKGROUND

• Shorr AF, Wu C, Kothari S. Outcomes with micafungin in patients with candidaemia or invasive candidiasis due to Candida glabrata and Candida krusei. J Antimicrob Chemother. 2011 Feb;66(2):375-80. doi: 10.1093/jac/dkq446. Epub 2010 Dec 8.

  PMID: 21147825 DERIVED

MeSH Terms

Conditions

Candidiasis; Candidemia

Interventions

Micafungin; Caspofungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Candidiasis, Invasive; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Central Contact

  Astellas Pharma US, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2005
• First Posted: March 8, 2005
• Study Start: September 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

CA (16); NL (1); CR (1); ES (13); AU (1); DE (7); CZ (1); CH (1); GB (7); PL (3); US (62); FR (9); BE (7); IN (21); BR (17)