Effect of the Association of a Statin to Antibiotics on the Prognosis of Patients Presenting With a Suspicion of Ventilator-associated Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The Primary efficacy measure is hospital mortality to day 28.
研究概览
简要总结
The objective is to assess the efficacy and safety of oral simvastatin in patients with a suspicion of ventilator-associated pneumonia (VAP). The hypothesis of this study is that simvastatin therapy will improve mortality in patients a suspicion of VAP.
详细描述
When a patient will present a suspicion of VAP (Clinical Pulmonary Infection Score modified ≥ 5), Simvastatin or placebo will be administered with antibiotics. Quantitative cultures will be performed for microbiological confirmation of VAP. Simvastatin or placebo will be administered through an enteral feeding tube or administered orally when patients are able to safely take oral medications. The type and placement of the enteral feeding tube (nasogastric, nasoenteric, PEG, orogastric, oroenteric, etc.) and the ability to safely take oral medications will be determined by the patient's primary team. Study drug will be blinded with an identical appearing placebo.
Sequential Organ Failure Assessment score (SOFA), and various blood factors will be measured during treatment.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Duration of mechanical ventilation > 48 h
- •First episode of suspicion of VAP with a Clinical Pulmonary Infection Score modified ≥ 5
- •BAL, plugged telescopic catheter and/or tracheal aspirates quantitative cultures performed prior administration of antibiotics
- •Informed consent
排除标准
- •Statin treatment received under mechanical ventilation
- •Age less than 18 years
- •Pregnancy
- •Unable to receive or unlikely to absorb enteral study drug
- •Patient, surrogate, or physician not committed to full support ).
- •Moribund patient with a SAPS II score > 75
- •Simvastatin specific exclusions Allergy or intolerance to statins Physician insistence for the use or avoidance of statins during the current hospitalization CK , ALT or AST > 5 times the upper limit of normal Receiving cyclosporine, gemfibrozil, lopinavir, ritonavir itraconazole, kétoconazole, érythromycine, clarithromycine, télithromycine, néfazodone, verapamil, diltiazem
- •Severe chronic liver disease
研究组 & 干预措施
PLACEBO
Half of the patients will be randomized to the placebo
干预措施: PLACEBO (Drug)
Simvastatin
Half of the subjects will receive the active drug, Simvastatin.
干预措施: SIMVASTATIN (Drug)
结局指标
主要结局
The Primary efficacy measure is hospital mortality to day 28.
时间窗: 28 days after randomization
次要结局
未报告次要终点