Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

Astellas

Status and phase: Completed; Phase 3

Conditions: Candidemia; Candidiasis

Treatments: Drug: Micafungin; Drug: Caspofungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00105144

03-0-192

Details and patient eligibility

About

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.

Full 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.

Enrollment: 611 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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611 participants in 3 patient groups

1

Experimental group

Description:

lower dose

Treatment:

Drug: Micafungin

2

Experimental group

Description:

higher dose

Treatment:

Drug: Micafungin

3

Active Comparator group

Treatment:

Drug: Caspofungin