Trial of Antimicrobial Restraint in Presumed Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- protocol adherence
研究概览
简要总结
The objective of this cluster-randomized crossover study is to determine the effect of delaying antimicrobial initiation until objective microbiologic data is obtained in patients with presumed ICU-acquired pneumonia without septic shock.
详细描述
This study will involve 8 centers is to determine the effect of delaying antimicrobial initiation until objective microbiologic data is obtained in patients with presumed ICU-acquired pneumonia without septic shock. The study team will compare two sequential 4-month periods in each unit, one 'aggressive' antimicrobial initiation period and one 'conservative' antimicrobial initiation period.
This study will serve the following specific aims:
Specific Aim 1: To determine feasibility of a larger multicenter study of the same design as well as assess protocol adherence across multiple centers.
Specific Aim 2: Prospectively determine the all-cause, in-hospital mortality for all patients with suspected pneumonia who were treated under either an aggressive or conservative antimicrobial initiation protocol.
Specific Aim 3: Prospectively determine antimicrobial initiation rates, total days of antimicrobial administration, hospital and ICU length of stay, and ventilator-free alive days for patients treated under each protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intubated patients admitted to a surgical or trauma intensive care unit that have had an appropriate quantitative or semi-quantitative endobronchial sputum culture sent ≥48 hours into their ICU admission
- •Primary pathology managed by surgical specialty
- •Age ≥18 years.
排除标准
- •Non-intubated patients.
- •Intubated patients with concern for active infection that is not suspected to be pneumonia (i.e. intra-abdominal infection, skin and soft tissue infection, urinary tract infection, etc.)
- •Primary disease not surgical or traumatic in nature
- •Primary diagnosis of burns
- •Incarcerated status
- •Pregnant status or delivery during this hospitalization.
- •On active immunosuppressive medications (or taking as a home medication prior to arrival)
结局指标
主要结局
protocol adherence
时间窗: by time of culture finalization or 1 week
as a pilot study the primary outcome will be protocol adherence as defined by using the criteria below: Aggressive Protocol: * Failure to send appropriate culture before initiation of antimicrobials in the absence of septic shock * Failure to stop antimicrobials in the absence of pneumonia or other documented infection after 72 hours. Conservative Protocol: * Failure to send appropriate culture * Initiation of antimicrobials (in the absence of septic shock, new onset or worsening organ dysfunction, or other indicated source of infection) without any objective evidence of pneumonia. * Failure to initiate antimicrobials in the setting of objective evidence of pneumonia. * Failure to stop antimicrobials in the absence of other documented infection if final cultures return as negative.
次要结局
- ICU length of stay(Until discharge from ICU or 1 year)
- Days of antimicrobials administered(until hospital discharge or 1 year)
- Hospital length of stay(until hospital discharge or 1 year)
- In-hospital mortality(until hospital discharge or 1 year)
- Ventilator-free alive days(until hospital discharge or 1 year)