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Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

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Astellas

Status and phase

Completed
Phase 3

Conditions

Candidemia
Invasive Candidiasis

Treatments

Drug: fluconazole
Drug: Micafungin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00189709
MCFGCAN-0301F-TW

Details and patient eligibility

About

To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia

Full description

Micafungin (a new class of antifungal drugs) is compared to fluconazole (current standard treatment) in the treatment of patients with serious fungal infections (invasive candidiasis and candidemia) to determine its efficacy and safety. Patients, both male and female, aged over 16 and with confirmed disease by the doctor could be recruited and evaluated.

Enrollment

24 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a confirmed diagnosis of candidemia and invasive candidiasis
  • Patients could be newly diagnosed with candidiasis who received no more than 48 hours of prior systemic antifungal therapy
  • Inpatients aged 16 and above

Exclusion criteria

  • Patients with serious invasive candidiasis whose prognoses are considered to be poor (life expectancy judged to be less than 5 days).
  • Patients with severe complications in the liver
  • Pregnant or lactating women
  • Patients who have received at least 5 days of prior systemic treatment of fluconazole or echinocandin with no response.
  • Patients who have prior antifungal infection requiring treatment with systemic antifungal agents for conditions other than candidemia and invasive candidiasis.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: Micafungin
2
Active Comparator group
Treatment:
Drug: fluconazole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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