Use of micafungin as antifungal prophylaxis in patients undergoing hematopoietic stem cell transplantation.

UMIN ID: UMIN000001905

Registered date:01/05/2009

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: hematological malignancies
• Date of first enrollment: 2009/05/01
• Target sample size: 65
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients receives a 50-mg dose of micafungin once daily as a 1-hour infusion. This prophylaxis is initiated within 24 hours of the beginning of the transplant-related conditioning regimen. Patients receives the prophylaxis until the earliest of the following: < 5 days after engraftment (defined as an absolute neutrophil count of 500 cells/mm3 after the nadir absolute count).

Outcome(s)

• Primary Outcome: The primary end point is treatment success, which is defined as the absence of fungal infection through the prophylaxis therapy of micafungin and as the absence of fungal infection through the end of the 4-week posttreatment period.

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: Patients are free of fungal infection at the time of enrollment. Patients have a history of a serious allergy to the study drug. Patients have a serious liver dysfunction. Patients have received micafungin within 7 days before the time of enrollment.

Related Information

• Primary Sponsor: The Jikei university school of medicine
• Source(s) of Monetary Support: The Jikei university school of medicine