Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,225
- 试验地点
- 1
- 主要终点
- Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population
研究概览
简要总结
To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.
- •Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.
- •Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.
排除标准
- •Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding).
- •Subjects with severe neutropenia (<500 cells/mm3)
- •Subjects with hypersensitivity to oxazolidinones or vancomycin.
研究组 & 干预措施
1
Subjects receiving linezolid for the treatment phase of the study
干预措施: linezolid (Zyvox) (Drug)
2
Subjects receiving vancomycin for the treatment phase of the study
干预措施: vancomycin (Drug)
结局指标
主要结局
Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population
时间窗: EOS (7-30 days after last dose)
Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.
次要结局
- Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population(EOS (7-30 days after last dose))
- Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population(EOT (within 72 hours of last dose))
- Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population(EOT (within 72 hours of last dose))
- Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population(EOS (7-30 days after last dose))
- Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population(EOS (7-30 days after last dose))
- Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population(EOT (within 72 hours of last dose))
- Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population(EOT (within 72 hours of last dose))
- Number of Participants With Clinical Signs and Symptoms at EOS for PP Population(EOS (7-30 days after last dose))
- Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population(EOS (7-30 days after last dose))
- Number of Participants With Clinical Signs and Symptoms at EOT for PP Population(EOT (within 72 hours of last dose))
- Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population(EOT (within 72 hours of last dose))
- Survival Status Estimated by Kaplan-Meier Analysis for PP Population(From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.)
- Survival Status Estimated by Kaplan-Meier Analysis for mITT Population(From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.)
- Survival Status Estimated by Kaplan-Meier Analysis for ITT Population(From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.)