Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00105144

Enrollment

611

Registered

2005-03-08

Start date

2004-09-30

Completion date

2006-04-30

Last updated

2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidemia, Candidiasis

Keywords

Treatment Effectiveness, Treatment Efficacy, Investigational, Therapies, Antifungal, Systemic, Antibiotics, Antifungal, Micafungin

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.

Interventions

DRUGMicafungin

DRUGCaspofungin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy	End of therapy and 6 weeks post-treatment

Secondary

Measure	Time frame
Overall treatment success, based on the Data Review Panel's assessment of pre-defined clinical and mycological response at the End of IV Therapy	End of therapy and 6 weeks post-treatment

Countries

Austria, Belgium, Brazil, Canada, Croatia, Czechia, France, Germany, India, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026