ACTRN12623000958684终止2 期
The Prophylaxis against Early Ventilator Associated Lower Respiratory Tract Infection (PREVENT LRTI) trial. A phase 2 multi-centre, randomized, double-blind, placebo-controlled parallel group clinical trial.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •1.Aged greater than or equal to 18 years AND
- •2.Invasively mechanically ventilated with one or more of the following acute brain injuries/conditions:
- •(i)Ischaemic stroke
- •(ii)Intracerebral haemorrhage
- •(iii)Status epilepticus
- •(iv)Subarachnoid haemorrhage
- •(v)Suspected hypoxic ischaemic encephalopathy following resuscitation from cardiac arrest
- •(vi)Traumatic brain injury.
- •3.Expected to be invasively ventilated (via endotracheal tube or tracheostomy) in the ICU until at least the day after tomorrow.
排除标准
- •1.Being treated with antibiotics to treat a known or suspected infection
- •2.Has been treated with antibiotics for a known or suspected infection in the previous 7 days
- •3.On prophylactic antibiotics except for peri-operative prophylaxis with cephazolin (or the treating clinician intends administering prophylactic antibiotics apart from peri-operative prophylaxis with cephazolin.) (SDD is counted as prophylactic antibiotics for the purposes of this exclusion)
- •4.More than 12 hours since intubation (or tracheostomy insertion)
- •5.More than 72 hours since hospital admission
- •6.Documented allergy or other contraindication to ceftriaxone
- •7.Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient or the substitute decision maker are not committed to full active treatment.
研究者
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