Phase II study of micafungin as empirical antifungal therapy for febrile neutropenic patients (C-SHOT 0503 study)

UMIN ID: C000000382

Registered date:30/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Febrile neutropenia
• Date of first enrollment: 2006/04/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Micafungin intravenously over 1 hour at a daily dose of 150 mg

Outcome(s)

• Primary Outcome: Rate of treatment success as defined by a 4-component composite endpoint (defervescence, development of breakthrough fungal infections, discontinuation of the study drug, and death)
• Secondary Outcome: Incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: (1) Past history of allergic reaction to the study drug; (2) MIcrobiological documented infection; (3) Having received systemic antifungal of antiviral therapy within 14 days; (4) Septic shock; (5) Allogeneic transplantation; (6) Body weight of less than 25 kg; (7) Positive for HIV antibody; (8) Pregnant or lactating woman

Related Information

• Primary Sponsor: Center for Supporting Hematology-Oncology Trials (C-SHOT)
• Source(s) of Monetary Support: Astellas Corporation