Voriconazole In High-Risk Patients With Invasive Fungal Infections In Slovakia. An Open, Prospective, Non-Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 177
- 主要终点
- Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active Treatment
Patients who are eligible for voriconazole treatment according to their physician decision.
干预措施: voriconazole (VFEND®) (Drug)
结局指标
主要结局
Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
时间窗: 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.
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
时间窗: 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.
Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit
时间窗: up to 2 weeks (EOT visit)
Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.
Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit
时间窗: up to 2 weeks (EOT visit)
Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.
次要结局
未报告次要终点