NCT00572559已完成4 期
A Randomized, Open Label, Multi-Center Clinical Trial, Comparing Microbiologic Response To Linezolid And Vancomycin In Ventilator-Associated Pneumonia (VAP) Due To Methicillin Resistant Staphylococcus Aureus (MRSA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- To assess early microbiologic response in patients with VAP due to MRSA based on semi-quantitative culture of bronchoscopic bronchoalveolar lavage (BAL) in patients treated with linezolid vs vancomycin.
研究概览
简要总结
Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals. Ineffective treatment of MRSA VAP clearly leads to prolonged mechanical ventilation and is probably associated with higher mortality. The purpose of this protocol is to directly compare linezolid and vancomycin specifically for MRSA VAP.
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
- None
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
- •The patient must have or be suspected of having a ventilator-associated pneumonia (VAP) due to MRSA.
- •Patient must be hospitalized for at least 5 days, must be ventilator-dependent ≥ 48 hours prior to screen/baseline, and anticipated to remain on the ventilator for 72 hours after enrollment so follow-up BAL can be performed.
- •Clinical picture compatible with pneumonia (acquired during ventilation)
- •Chest X Ray at baseline/screen or within 24 hours of initiation of therapy must be consistent with diagnosis of pneumonia
排除标准
- •Hypersensitivity to linezolid, vancomycin, or one of the excipients in any of these drug formulations.
- •Infections due to gram-positive organisms known to be resistant to either of the study drugs.
- •Any antibiotic used in the treatment of MRSA, such as vancomycin, TMP/SMX, rifampin, or linezolid, for more than 48 hours prior to patient's enrollment into the study.
- •Patients with neutropenia, AIDS, lymphoma or anticipated chemotherapy.
- •Patients who have long-term tracheostomy (for more than 60 days). Acute tracheostomy patients are allowed.
研究组 & 干预措施
1
Experimental
干预措施: Vancomycin (Drug)
2
Experimental
干预措施: Linezolid (Drug)
结局指标
主要结局
To assess early microbiologic response in patients with VAP due to MRSA based on semi-quantitative culture of bronchoscopic bronchoalveolar lavage (BAL) in patients treated with linezolid vs vancomycin.
时间窗: 72-96 hours
次要结局
- To compare duration of mechanical ventilation(0000)
- To compare post treatment tracheal colonization(FU: 14 days after EOT +/- 2 days)
- To identify clinical correlates of infection based on microbiologic sampling as determined by original and modified CPIS (Clinical Pulmonary Infection Score)(EOT: Day 14; FU: 14 days after EOT +/- 2 days)
- To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure(72-96 hours)
- To compare mortality at End Of Treatment (EOT) and Follow up (FU); To compare clinical outcome at EOT and FU(EOT: Day 14; FU: 14 days after EOT +/- 2 days)
研究者
研究点 (1)
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