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

Phase 2

• Conditions: Febrile neutropenia

• Registration Number: JPRN-C000000382
• Lead Sponsor: Center for Supporting Hematology-Oncology Trials (C-SHOT)

Brief Summary

Of the 78 evaluable patients, 54 (69 %) achieved defervescence by the time of neutrophil recovery, and 56 (72 %) completed the treatment in accordance with the provision of the protocol. Four patients developed invasive fungal infection, nine changed antifungal therapy because of lack of efficacy, and three discontinued micafungin because of drug-related adverse events. Based on the composite end point taking account of these, the overall treatment success rate was 60 %, with the lower limit of a 90 % confidence interval (50.3 %) exceeding the predefined threshold success rate (50 %).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-30
• Study Completion: 2010-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified