De-escalation of Antifungal Treatment in Immunocompromised Critically Ill Patients With Suspected Invasive Candida Infection: Incidence, Associated Factors, and Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Percentage of patients with de-escalation of antifungal treatment
研究概览
简要总结
A small proportion of intensive care unit patients receiving antifungals have a proven invasive fungal infection. However, antifungal treatment has side effects such as toxicity, emergence of resistance, and high cost. Moreover, empirical antifungal treatment is still a matter for debate in these patients. Our study aimed to determine the incidence, associated factors, and safety of de-escalation of antifungals in immunocompromised critically ill patients.
This prospective observational study is conducted in 14 ICU, during a 6 months period. All immunocompromised patients hospitalized for >5d and treated with antifungals for suspected or proven invasive candida infection will be included De-escalation is defined as a reduction in antifungal spectrum or stopping initial drugs within the 5 days following their initiation. The three antifungals considered in this study are from the narrowest to the widest spectrum: fluconazole, caspofungin and liposomal amphotericin B.
详细描述
This is a retrospective and prospective observational multicenter study, aiming to determine the incidence, and safety of antifungal de-escalation in immunocompromised patients, and also factors associated with de-escalation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults immunocompromised patients hospitalized in intensive care units
- •Predictable invasive mechanical ventilation duration > 96h
- •Signed consent (by patient or its representative)
- •First antifungal treatment initiation in ICU for proven or suspected candida infection
排除标准
- •Pregnant or breast-feeding women.
- •Fungal infection other than invasive candida
- •Prophylactic antifungal treatment.
- •Lack of informed consent
- •Predictable mechanical ventilation duration less than 48 hours
- •Patients discharged from ICU before the 5th day after initiation of TAF
结局指标
主要结局
Percentage of patients with de-escalation of antifungal treatment
时间窗: 5 days following start of antifungal treatment
De-escalation is defined as a reduction in antifungal treatment spectrum (switch from echinocandines or Amphotericin B to Azoles) or stopping all antifungals within the 5 days following their initiation
次要结局
- Number of days free of mechanical ventilation(until day 28 after start of antifungal treatment)
- All-cause mortality(until day 28 after start of antifungal treatment)
- Percentage of patients with reoccurrence of candidiasis(until day 7 after stop of antifungal treatment)
- Number of days free of antifungal treatment(until day 28 after start of antifungal treatment)
- Risk factors for de-escalation of antifungal therapy(during the 5 days following start of antifungal)
- Length of ICU stay(until day 28 after start of antifungal treatment)