CandidiasisPhase 3NCT00105144
Study of Micafungin in Patients With Invasive Candidiasis or Candidemia
A Phase 3 study testing Micafungin and Caspofungin in people with Candidiasis and Candidemia, run by Astellas Pharma Inc at 167 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis, Candidemia
- What is being tested?
- Micafungin and Caspofungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 167 sitesin 15 countries
- Study dates
- Sep 2004to Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have candidemia or invasive candidiasis.
Who cannot join
- 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.
Trial locations and contacts
167 sites in 15 countries.
167 sites in 15 countries
United States62 sites
Study site
Albany, New York, 12208
Study site
Allentown, Pennsylvania, 18103
Study site
Atlanta, Georgia, 30322
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Augusta, Georgia, 30909
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Augusta, Georgia, 30912
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Baltimore, Maryland, 21201
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Baltimore, Maryland, 21287
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Bay Pines, Florida, 33744
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Beech Grove, Indiana, 46107
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Birmingham, Alabama, 35294
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Boston, Massachusetts, 02111
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Boston, Massachusetts, 02115
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Boston, Massachusetts, 02215
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Charlottesville, Virginia, 22908
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Chicago, Illinois, 60612
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Chicago, Illinois, 60637
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Cincinnati, Ohio, 45267
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Columbus, Ohio, 43210
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Dallas, Texas, 75246
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Denver, Colorado, 80204
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Denver, Colorado, 80262
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Des Moines, Iowa, 50309
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Detroit, Michigan, 48201
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Detroit, Michigan, 48202
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Durham, North Carolina, 27710
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Evansville, Indiana, 47714
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Fairfax, Virginia, 22030
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Houston, Texas, 77030
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Iowa City, Iowa, 52242
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Jackson, Mississippi, 39216
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Jackson, Tennessee, 38301
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Kansas City, Kansas, 66160
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Lexington, Kentucky, 40536
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Little Rock, Arkansas, 72205
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Los Angeles, California, 90033
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Los Angeles, California, 90095
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Manhasset, New York, 11030
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Maywood, Illinois, 60153
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Memphis, Tennessee, 38104
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Miami, Florida, 33136
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Minneapolis, Minnesota, 55455
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Neptune City, New Jersey, 07754
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New Hyde Park, New York, 11040
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New Orleans, Louisiana, 70121
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New York, New York, 10029
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New York, New York, 10032
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Philadelphia, Pennsylvania, 19104
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Philadelphia, Pennsylvania, 19140
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Pittsburgh, Pennsylvania, 15213
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Providence, Rhode Island, 02908
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Rochester, New York, 14642
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San Antonio, Texas, 78229
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San Francisco, California, 94115
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Seattle, Washington, 98109
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St Louis, Missouri, 63310
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Stony Brook, New York, 11794
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The Bronx, New York, 10467
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Valhalla, New York, 10595
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Washington D.C., District of Columbia, 20010
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West Reading, Pennsylvania, 19611
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Wichita, Kansas, 67214
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Winston-Salem, North Carolina, 27157
India21 sites
Study site
Bangalore, 560017
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Bangalore, 56017
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Bangalore
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Banglore, 560 054
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Chandigarh
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Chennai, 35
Study site
Chennai, 600 006
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Cochin Kerala, 682 026
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Hyderabad, 500 009
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Hyderabad, 500 033
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Hyderabad, 500 034
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Hyderabad, 500 082
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Kochi
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Kolkotta, 700 029
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Lucknow, 226 014
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Ludhiana, 141 009
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Mangalore, 575 001
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Manipal, 576 104
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Mumbai, 400 012
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Mumbai, 400 026
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Uttar Pradesh, 201 301
Brazil17 sites
Study site
Belo Horizonte, Mg-cep, 30140-093
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Belo Horizonte, Mg-cep, 30190-081
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Belo Horizonte, Minas Gerais, 30190-081
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Belo Horizonte, 30110-908
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Belo Horizonte, 30130-110
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Belo Horizonte, 30190-130
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Cunitiba, Pr-cep, 80060-900
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Porto Alegre, Rio Grande do Sul
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Rio de Janeiro, Rio de Janeiro, 21941-590
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Salvador, 40050-410
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Salvador, 40110-160
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Santos, São Paulo, 11045-904
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São José do Rio Preto, São Paulo, 15090-000
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São Paulo, São Paulo, 04039-020
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São Paulo, 01500-000
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São Paulo, 04012-180
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São Paulo, 04040-002
Canada16 sites
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Chicoutimi, Quebec, G7H 5H6
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Edmonton, Alberta, T6G 2B7
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Greenfield Park, Quebec, J4V 2H1
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Halifax, Nova Scotia, B3H 1V7
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Hamilton, Ontario, L8V 1C3
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Kelowna, British Columbia, V1Y 1T2
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Kingston, Ontario, K7L 2V7
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H2X 2P4
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Ottawa, Ontario, K1H 8L6
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Québec, Quebec, G1R 2J6
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Regina, Saskatchewan, S4P 0W5
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Saskatoon, Saskatchewan, S7N 0W8
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St. John's, Newfoundland and Labrador, A1B 3V6
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Toronto, Ontario, M5G 2N2
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Winnipeg, Manitoba, R3A 1R9
Spain13 sites
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Barakaldo, 48903
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Barcelona, 08003
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Barcelona, 08025
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Barcelona, 08035
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Barcelona, 08036
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Madrid, 28005
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Madrid, 28007
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Madrid, 28034
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Madrid, 28041
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Salamanca, 37007
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Santander, 39008
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Seville, 41014
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Valencia, 46009
France9 sites
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Bobigny, 93009
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Metz, 57000
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Paris, 75181
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Paris, 75651
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Paris, 75674
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Paris, 75877
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Strasbourg, 67098
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Villejuif, 94084
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Villejuif, 94805
Belgium7 sites
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Aalst, 9300
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Brussels, 1000
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Brussels, 1070
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Brussels, 1090
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Brussels, 1200
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Ghent, 9000
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Liège, 4800
Germany7 sites
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Berlin, 10117
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Bielefeld, 33611
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Cologne, 50937
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Frankfurt, 60590
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Hanover, 30625
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Ulm, 89081
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Würzburg, 97070
United Kingdom7 sites
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Glasgow, GB, G11 6NT
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Leeds, GB, LS1 3EX
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Leeds, GB, LS9 7TF
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London, England, SE1 7EH
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London, England, SW10 9NH
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London, England, W6 8RF
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Manchester, England, M23 9LT
Poland3 sites
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Gdansk, 80-211
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Lodz, 93-513
Study site
Warsaw, 00-957
About this study
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
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.
Read the 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.
- Conditions
- Candidiasis, Candidemia
- Being tested
- Micafungin, Caspofungin
- Keywords
- Treatment Effectiveness, Treatment Efficacy, Investigational, Therapies, Antifungal, Systemic, Antibiotics, Antifungal, Micafungin
- Medical subject headings
- Candidiasis, Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called Mycamine, FK463
IV
CaspofunginDrug
Also called Cancidas
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | lower dose Receives: Drug: Micafungin |
| 2 | Experimental | higher dose Receives: Drug: Micafungin |
| 3 | Active comparator | Not described Receives: Drug: Caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy
Measured: 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
Measured: End of therapy and 6 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2005 (estimated)
- Study startSep 2004
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105144
- Sponsor's protocol ID
- 03-0-192
- Status last verified
- Sep 2014
- First submitted
- 7 Mar 2005
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17806055Shorr 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.
PubMed 21147825
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00105144
- Acronym / sponsor ID
- 03-0-192
- Conditions
- Candidiasis, Candidemia
- Keywords
- Treatment Effectiveness, Treatment Efficacy, Investigational, Therapies, Antifungal, Systemic, Antibiotics, Antifungal, Micafungin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 8 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Micafunginlower dose |
| 2 | Experimental | Drug: Micafunginhigher dose |
| 3 | Active comparator | Drug: Caspofungin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have candidemia or invasive candidiasis.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicafunginAlso: Mycamine, FK463IV | Drug | 1, 2 |
| CaspofunginAlso: CancidasIV | Drug | 3 |
Primary outcome
Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy
Time frame: End of therapy and 6 weeks post-treatment
1 secondary outcome
Overall treatment success, based on the Data Review Panel's assessment of pre-defined clinical and mycological response at the End of IV Therapy
Time frame: End of therapy and 6 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
- Background: PubMed 17806055Pappas 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.
- Derived from this study: PubMed 21147825Shorr 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study director
Astellas Pharma US, Inc.
167 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Micafungin and Caspofungin in people with Candidiasis and Candidemia, run by Astellas Pharma Inc at 167 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 167 sites in United States, India, Brazil, Canada, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy (time frame: End of therapy and 6 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.