An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Diagnosis of Systemic Fungal Infection (SFI)
研究概览
简要总结
To collect and summarize information on the diagnosis, management, and clinical and mycological outcomes of patients with systemic fungal infections in order to better understand the effectiveness of antifungals in the treatment of Systemic Fungal Infections (SFI) in India.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for enrollment in the study database, patients must have received (in the Intensive Care Unit [ICU] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection.
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: voriconazole (Drug)
结局指标
主要结局
Diagnosis of Systemic Fungal Infection (SFI)
时间窗: Up to 9 months
Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.
Management of SFI: Choice of Treatment
时间窗: Up to 9 months
Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.
Management of SFI: Reason for Selection of Antifungal Agent
时间窗: Up to 9 months
Number of participants with reason for investigator's selection of particular antifungal therapy.
Total Daily Dose for Selected Antifungal Agent
时间窗: Up to 9 months
Number of Participants With Clinical Outcomes.
时间窗: Up to 9 months
Clinical outcomes, as assessed by the investigator, defined as: Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period. Deteriorated: clinical signs and symptoms of fungal infection worsened (including death). Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation.
Number of Participants With Mycological Outcomes
时间窗: Up to 9 months
Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy ), or unknown (results are not available/not known) as assessed by the Investigator/Physician.
次要结局
- Concomitant Medications(Up to 9 months)
- Median Duration of Antifungal Therapy(Up to 9 months)
- Medication Administration(Up to 9 months)