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临床试验/NCT00704951
NCT00704951撤回不适用

P05532 Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections (IFIs) in Immuncompromised Patients in Austria. Version 1, 08-Nov-2007.

Merck Sharp & Dohme LLC0 个研究点开始时间: 2008年7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
撤回
主要终点
Safety: adverse events

研究概览

简要总结

The purpose of this program is to determine the frequency of the use of Posaconazole in immunocompromised patients refractory to first line therapy receiving therapeutic treatment based on different pathogens in comparison to other antifungal therapy.

A further objective is to determine the frequency of the use of Posaconazole in immunocompromised patients receiving prophylactic treatment in comparison to other antifungal prophylaxis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Immunocompromised patients with refractory IFI
  • Patients eligible for prophylactic treatment due to anticipated neutropenia for more than 7 days.

排除标准

  • 未提供

研究组 & 干预措施

Patients

Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections

干预措施: Posaconazole or alternative fungal treatment (Drug)

结局指标

主要结局

Safety: adverse events

时间窗: Depending on treatment modality every 2 to 4 weeks

次要结局

  • Baseline: Patient demographic data; Disease history; Underlying diseases; Diagnosis; Previous therapies; Environmental risk factors; Host factors Performance status(Depending on treatment modality every 2 to 4 weeks)
  • Treatment and follow up period: Performance status; Medication; Duration of treatment; Frequency of infectious episodes; Management of infections(Depending on treatment modality every 2 to 4 weeks)
  • Adverse events; Survival status(Depending on treatment modality every 2 to 4 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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