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Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection (Ve-RIFI)

2011年8月31日 更新者:Pfizer

Voriconazole In High-Risk Patients With Invasive Fungal Infections In Slovakia. An Open, Prospective, Non-Comparative Study

Assessment of safety and efficacy of voriconazole in real-life setting in the treatment of high risk patients with invasive fungal infections. The study is conducted in Slovakia only.

研究概览

地位

完全的

研究类型

观察性的

注册 (实际的)

177

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2年 及以上 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Male or female patients older than 2 years with invasive fungal infections.

描述

Inclusion Criteria:

  • Male or female patient of age 2 years or older.
  • High-risk patients with proven, probable or possible invasive fungal infection (IFI) according to the EORTC/MSG criteria.
  • Patients indicated for secondary prophylaxis of invasive aspergillosis.

Exclusion Criteria:

  • Patients with known hypersensitivity to voriconazole or to any of the excipients.
  • Patients with contraindicated concomitant medications according to the SmPC.
  • Children less than 2 years of age.
  • Pregnancy and lactation.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Active Treatment
Patients who are eligible for voriconazole treatment according to their physician decision.
The use and dosage recommendations for voriconazole (VFEND®) will take place on the basis of the Summary of Product Characteristics (SmPC) and will be adjusted solely according to medical and therapeutic necessity. The formulation and dose will be managed by the treating physician according to the SmPC, disease and clinical situation. According to the SmPC, in the adults the treatment should be started with the loading dose of 6 mg/kg of voriconazole iv. every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg BID. For peroral formulations, the initial dose should be depending on the weight of the patient 400 mg or 200 mg BID during the first 24 hrs, followed by the maintenance dose of 200 mg or 100 mg of voriconazole BID respectively For paediatric population (<12 years of age), there is no initial dose necessary. Depending on the formulation, the daily dosage should be in children 7 mg/kg iv. BID or 200 mg of voriconazole orally BID.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
大体时间:up to 2 weeks (EOT visit)
Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.
up to 2 weeks (EOT visit)
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
大体时间:more than 2 weeks (Test-of-Cure visit)
Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.
more than 2 weeks (Test-of-Cure visit)
Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit
大体时间:up to 2 weeks (EOT visit)
Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.
up to 2 weeks (EOT visit)
Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit
大体时间:up to 2 weeks (EOT visit)
Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.
up to 2 weeks (EOT visit)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年4月1日

初级完成 (实际的)

2009年11月1日

研究完成 (实际的)

2009年11月1日

研究注册日期

首次提交

2010年6月2日

首先提交符合 QC 标准的

2010年6月3日

首次发布 (估计)

2010年6月4日

研究记录更新

最后更新发布 (估计)

2011年9月2日

上次提交的符合 QC 标准的更新

2011年8月31日

最后验证

2011年8月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

voriconazole (VFEND®)的临床试验

3
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