Clinical trial NCT00105144: Study of Micafungin in Patients With Invasive Candidiasis or Candidemia
Official title: A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candidiasis
Candidemia
Keywords: Treatment Effectiveness
Treatment Efficacy
Investigational, Therapies
Antifungal, Systemic
Antibiotics, Antifungal
Micafungin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2005-03-08
Enrollment: 611
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy
timeFrame: End of therapy and 6 weeks post-treatment
Secondary outcomes:
measure: Overall treatment success, based on the Data Review Panel's assessment of pre-defined clinical and mycological response at the End of IV Therapy
timeFrame: End of therapy and 6 weeks post-treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Bay Pines
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Beech Grove
country: United States
state: Indiana
city: Evansville
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Neptune
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Stonybrook
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburg
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Jackson
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Wien
country: Austria
city: Aalst
country: Belgium
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Brussel
country: Belgium
city: Brussel
country: Belgium
city: Gent
country: Belgium
city: Liege
country: Belgium
city: Belo Horizonte
country: Brazil
state: Mg-cep
city: Belo Horizonte
country: Brazil
state: Mg-cep
city: Belo Horizonte
country: Brazil
state: MG
city: Cunitiba
country: Brazil
state: Pr-cep
city: Rio de Janeiro
country: Brazil
state: RJ
city: Porto Alegre
country: Brazil
state: RS
city: Santos
country: Brazil
state: SP
city: São José do Rio Preto
country: Brazil
state: SP
city: São Paulo
country: Brazil
state: SP
city: Belo Horizonte
country: Brazil
city: Belo Horizonte
country: Brazil
city: Belo Horizonte
country: Brazil
city: Salvador
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Edmonton
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
city: Zagreb
country: Croatia
city: Prague
country: Czech Republic
city: Bobigny
country: France
city: Metz
country: France
city: Paris Cedex 04
country: France
city: Paris Cedex 13
country: France
city: Paris Cedex 14
country: France
city: Paris Cedex 18
country: France
city: Strasbourg
country: France
city: Villejuif Cedex
country: France
city: Villejuif Cedex
country: France
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Frankfurt
country: Germany
city: Hannover
country: Germany
city: Koln
country: Germany
city: Ulm
country: Germany
city: Wurzburg
country: Germany
city: Bangalore
country: India
city: Bangalore
country: India
city: Bangalore
country: India
city: Banglore
country: India
city: Chandigarh
country: India
city: Chennai
country: India
city: Chennai
country: India
city: Cochin Kerala
country: India
city: Cochin
country: India
city: Hyderabad
country: India
city: Hyderabad
country: India
city: Hyderabad
country: India
city: Hyderabad
country: India
city: Kolkotta
country: India
city: Lucknow
country: India
city: Ludhiana
country: India
city: Mangalore
country: India
city: Manipal
country: India
city: Mumbai
country: India
city: Mumbai
country: India
city: Uttar Pradesh
country: India
city: Groningen
country: Netherlands
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Warsaw
country: Poland
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Salamanca
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: St. Gallen
country: Switzerland
city: London
country: United Kingdom
state: England
city: London
country: United Kingdom
state: England
city: London
country: United Kingdom
state: England
city: Manchester
country: United Kingdom
state: England
city: Glasgow
country: United Kingdom
state: GB
city: Leeds
country: United Kingdom
state: GB
city: Leeds
country: United Kingdom
state: GB
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.