Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis
NCT ID: NCT00665639
Last Updated: 2014-08-20
Study Results
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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COMPLETED
PHASE3
454 participants
INTERVENTIONAL
2004-06-30
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Daily dose
micafungin
IV
2
caspofungin
IV
3
Every other day dose, alternating with placebo
micafungin
IV
Interventions
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micafungin
IV
caspofungin
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Negative pregnancy test for female patients of childbearing potential
Exclusion Criteria
* Evidence of liver disease
* Another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
* Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
* Received an oral or topical antifungal agent within 48 hours or a systemic antifungal agent within 72 hours of first dose of study drug
* Known to be non-responsive to therapy in any prior systemic antifungal clinical trail
* Experienced \> 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
* History of anaphylaxis attributed to echinocandin class of antifungals
16 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use central contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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5 Sites
Buenos Aires, , Argentina
Córdoba, , Argentina
Neuquén, , Argentina
Santa Fe, , Argentina
Barretos, , Brazil
3 Sites
Belo Horizonte, , Brazil
Boqueirao-Santos, , Brazil
Campinas, , Brazil
2 Sites
Curitiba, , Brazil
Nova Iguaçu, , Brazil
Parquelandia-Fortaleza, , Brazil
7 Sites
São Paulo, , Brazil
4 Sites
Lima, , Peru
Gaborone, Botswana, South Africa
Windoek, Nambia, South Africa
Arcadia-Pretoria, , South Africa
Benoni, , South Africa
2 Sites
Bloemfontein, , South Africa
Cape Town, , South Africa
Centurion, , South Africa
Dundee, , South Africa
Durban, , South Africa
Hatfield-Pretoria, , South Africa
Olifantsfontein, , South Africa
2 Sites
Port Elizabeth, , South Africa
Potchefstroom, , South Africa
Pretoria, , South Africa
Pretoria West, , South Africa
Reiger Park, , South Africa
Richards Bay, , South Africa
Somerset West, , South Africa
Countries
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References
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Andes DR, Reynolds DK, Van Wart SA, Lepak AJ, Kovanda LL, Bhavnani SM. Clinical pharmacodynamic index identification for micafungin in esophageal candidiasis: dosing strategy optimization. Antimicrob Agents Chemother. 2013 Nov;57(11):5714-6. doi: 10.1128/AAC.01057-13. Epub 2013 Aug 19.
Other Identifiers
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03-7-008
Identifier Type: -
Identifier Source: org_study_id
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