Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

NCT ID: NCT00105144

Last Updated: 2014-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

611 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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The purpose of the study is to determine the efficacy and safety of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia. The maximum length of antifungal treatment is 4 weeks except in pre-defined patients where maximum length of therapy is 8 weeks. A post treatment assessment will be conducted at 2 weeks and 6 weeks after the last dose of all antifungal treatments.

Conditions

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Candidiasis Candidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

lower dose

Group Type EXPERIMENTAL

Micafungin

Intervention Type DRUG

IV

2

higher dose

Group Type EXPERIMENTAL

Micafungin

Intervention Type DRUG

IV

3

Group Type ACTIVE_COMPARATOR

Caspofungin

Intervention Type DRUG

IV

Interventions

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Micafungin

IV

Intervention Type DRUG

Caspofungin

IV

Intervention Type DRUG

Other Intervention Names

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Mycamine FK463 Cancidas

Eligibility Criteria

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Inclusion Criteria

* Patients must have candidemia or invasive candidiasis.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Birmingham, Alabama, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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

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Bay Pines, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Maywood, Illinois, United States

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Beech Grove, Indiana, United States

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Evansville, Indiana, United States

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Des Moines, Iowa, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Neptune City, New Jersey, United States

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Albany, New York, United States

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Manhasset, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Stony Brook, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Providence, Rhode Island, United States

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Jackson, Tennessee, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Fairfax, Virginia, United States

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Seattle, Washington, United States

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Vienna, , Austria

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Aalst, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Liège, , Belgium

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Belo Horizonte, Mg-cep, Brazil

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Belo Horizonte, Mg-cep, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Cunitiba, Pr-cep, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Santos, São Paulo, Brazil

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São José do Rio Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Belo Horizonte, , Brazil

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Belo Horizonte, , Brazil

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Belo Horizonte, , Brazil

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Salvador, , Brazil

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Salvador, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Regina, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Zagreb, , Croatia

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Prague, , Czechia

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Bobigny, , France

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Metz, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Strasbourg, , France

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Villejuif, , France

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Villejuif, , France

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Berlin, , Germany

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Bielefeld, , Germany

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Cologne, , Germany

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Frankfurt, , Germany

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Hanover, , Germany

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Ulm, , Germany

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Würzburg, , Germany

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Bangalore, , India

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Bangalore, , India

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Bangalore, , India

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Banglore, , India

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Chandigarh, , India

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Chennai, , India

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Chennai, , India

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Cochin Kerala, , India

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Hyderabad, , India

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Hyderabad, , India

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Hyderabad, , India

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Hyderabad, , India

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Kochi, , India

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Kolkotta, , India

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Lucknow, , India

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Ludhiana, , India

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Mangalore, , India

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Manipal, , India

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Mumbai, , India

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Mumbai, , India

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Uttar Pradesh, , India

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Groningen, , Netherlands

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Gdansk, , Poland

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Lodz, , Poland

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Warsaw, , Poland

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Barakaldo, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Salamanca, , Spain

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Santander, , Spain

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Seville, , Spain

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Valencia, , Spain

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Sankt Gallen, , Switzerland

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London, England, United Kingdom

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London, England, United Kingdom

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London, England, United Kingdom

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Manchester, England, United Kingdom

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Glasgow, GB, United Kingdom

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Leeds, GB, United Kingdom

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Leeds, GB, United Kingdom

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Countries

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United States Austria Belgium Brazil Canada Croatia Czechia France Germany India Netherlands Poland Spain Switzerland United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 17806055 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21147825 (View on PubMed)

Other Identifiers

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03-0-192

Identifier Type: -

Identifier Source: org_study_id

NCT00235742

Identifier Type: -

Identifier Source: nct_alias

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