Multicenter Randomized Clinical Trial of Antimicrobial Treatment in Ventilator-associated Tracheobronchitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 590
- 试验地点
- 30
- 主要终点
- Ventilator free days
研究概览
简要总结
The Ventilator Associated tracheobronchitis Initiative to Conduct Antibiotic evaluation (VATICAN) trial is a national, multicenter, non-inferiority trial in ICU patients comparing antibiotic treatment for 7 days versus clinical observation without antibiotic treatment for patients with ventilator-associated tracheobronchitis.
详细描述
There is no consensus on the need for antibiotic treatment for ventilator-associated tracheobronchitis (VAT). There's a lack of high-quality clinical data on this subject, and although some observational studies recommend antibiotic treatment for VAT, some guidelines do not. The VATICAN is a prospective, randomized, single-blinded (analysis), non-inferiority trial evaluating antibiotic treatment for patients with ventilator-associated tracheobronchitis. Patients with clinically diagnosed tracheobronchitis will be randomized to receive antibiotics for 7 days versus clinical observation without antibiotic treatment for VAT. The primary hypothesis is that clinical observation without antibiotic treatment is noninferior to 7-day antibiotic course.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Admission to one of the participating ICUs
- •Invasive Mechanical ventilation ≥ 48 hours
- •Available chest imaging of screening day
- •Clinical diagnosis of VAT, defined by the presence of:
- •Temperature >38.0°C or <36°C OR leukocytes >12000/mL or <4000/mL or presence >10% of immature forms, AND
- •Onset of purulent tracheal secretion, or change in characteristics of the secretion, or increase in the amount of respiratory secretion, or increased need for aspiration
- •Culture of tracheal secretion from the day of screening under analysis or collected for analysis
排除标准
- •Pregnant or lactating women
- •Indication of use of antibiotics or use of systemic antibiotics for any indications at the time of screening
- •Hemodynamic instability, defined as hypotension unresponsive to volume expansion or increase in vasopressor dose > 0.1mcg/kg/min of noradrenaline or equivalent in the past 6 hours
- •Worsening of gas exchange, defined as an increase in the fraction of inspired oxygen ≥ 20% or an increase in positive end-expiratory pressure (PEEP) ≥ 3 cm of water after a stability period ≥ 2 days
- •Prolonged mechanical ventilation, defined by use of invasive mechanical ventilation for 21 days or more
- •Presence of pulmonary radiological image suggestive of new infectious infiltrate
- •Previous lung disease that makes radiological interpretation for the diagnosis of VAP difficult
- •Previous diagnosis of ventilator associates pneumonia (VAP) during hospitalization
- •Neutropenic patients (neutrophils <1000/mL)
- •Known severe immunosuppression
- •Tracheostomized patients at the time of screening
- •Inclusion in the study in the past 30 days
- •Expected limitation of care or early withdrawal of supportive therapies (< 7 days)
- •Patients with a survival expectancy of less than 48 hours
- •Refusal of consent to participate in the study
研究组 & 干预措施
Clinical observation without antibiotic therapy for VAT
Patients will receive standard care and no antibiotic therapy for VAT. Antibiotics will be prescribed if other infections and/or organ dysfunction ensues (especially shock) or there is progression to pneumonia
干预措施: Clinical observation without antibiotic therapy for VAT (Other)
7 day antibiotic course for VAT
Patients will receive standard care and 7 day course of antibiotic therapy for VAT.
干预措施: 7 day antibiotic course for VAT (Other)
结局指标
主要结局
Ventilator free days
时间窗: 28 days after randomization
Days alive and free from mechanical ventilation
次要结局
- Cost analysis(For the first 28 days after randomization)
- Ventilator associated pneumonia-free survival (Key secondary outcome)(28 days after randomization)
- Mortality(28 days after randomization)
- Organ dysfunction(Between randomization and day 7.)
- Microbiological isolation of multi-resistant bacteria(28 days after randomization)
- Ventilator associated pneumonia(14 and 28 days after randomization)
- Intensive care unit free days(28 days after randomization)
- Antibiotic free days(28 days after randomization)