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临床试验/NCT02714504
NCT02714504已完成不适用

Evaluation of the Efficacy of Anti-mold Azole Prophylaxis in High-risk Hematologic Patients With Baseline Superficial Skin Lesions Positive for Fusarium Spp

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
239
试验地点
1
主要终点
Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery

研究概览

简要总结

Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened with dermatologic examination. In the presence of any skin lesion in the extremities, direct exam and fungal culture will be performed. If these exams indicate the presence of Fusarium species, patients will receive anti-mold azole prophylaxis

详细描述

Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened on admission. Patients may be included more than once, provided that a new treatment is administered and >30 days elapses from one to other admission (episode).

Screening will consist of a thorough physical examination in the extremities. In case of a skin lesion, direct exam and fungal culture will be performed. Nail samples will be obtained by scrapping the nails with a curette, and samples from interdigital areas will be obtained using swabs.

In a first phase no intervention will be performed. In a second phase, if direct exam and /or culture indicate the presence of Fusarium spp., primary antifungal therapy with an anti-mold azole (voriconazole (200 mg BID) or posaconazole (200 mg TID) will be started.

Patients will be followed until discharge. The primary endpoint is invasive fusariosis, comparing the observational period with the intervention period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • admission for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia

排除标准

  • prior documentation of invasive fusariosis or allergy to azoles

研究组 & 干预措施

Anti-mold prophylaxis

Experimental

Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.

干预措施: Voriconazole or posaconazole (Drug)

结局指标

主要结局

Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery

时间窗: Until neutrophil recovery, for an average of 4 weeks

Proportion of patients who develop invasive fusariosis until neutrophil recovery, for an average of 4 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcio Nucci

Associate Professor

Universidade Federal do Rio de Janeiro

研究点 (1)

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