Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia
2013年12月12日 更新者:Pfizer
Clinical Outcomes Among a National Veterans Affairs Methicillin Resistant Staphylococcus Aureus (MRSA) Pneumonia Cohort Treated With Linezolid Or Vancomycin
The purpose of this non-interventional, retrospective study of existing data is to evaluate clinical outcomes related to Methicillin-resistant Staphylococcus aureus hospital based pneumonia by treatment and among subpopulations.
研究概览
详细说明
All patients meeting inclusion/exclusion criteria from inpatient database from 1/1/02-9/30/10.
研究类型
观察性的
注册 (实际的)
5271
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
National database of inpatient admissions between January 1, 2002 and Septmeber 30, 2010
描述
Inclusion Criteria:
- MRSA and pneumonia cases by ICD-9 code identification.
- Diagnosis included during inpatient stay.
- Treatment initiation in hospital.
Exclusion Criteria:
- Death of discharge within 3 days of treatment initiation.
- Exposure to other treatments with MRSA activity.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
linezolid (Zyvox)
|
As prescribed-this is retrospective cohort of existing clinical data.
|
|
Vancomycin
|
As prescribed-this is retrospective cohort of existing clinical data.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to 30-day Mortality
大体时间:Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported.
Mortality was assessed from admission vital status databases.
|
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to Therapy Change
大体时间:Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
Time to therapy change was calculated from initiation of therapy (index date) to change in therapy (event date).
Therapy change was defined as the discontinuation of linezolid or vancomycin and initiation of a different agent with activity against MRSA (clindamycin, daptomycin, doxycycline, linezolid, minocycline, tigecycline, trimethoprim/sulfamethoxazole, vancomycin).
As such, therapy change included switching from linezolid to vancomycin, switching from vancomycin to linezolid, or switching from either linezolid or vancomycin to another anti-MRSA antibiotic.
|
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
|
Time to Discharge From the Hospital
大体时间:Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date).
|
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
|
Time to Transfer Out From the Intensive Care Unit (ICU)
大体时间:Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
Time to discharge from the ICU was calculated from the initiation of therapy (index date) to the time the participant was transferred out from ICU (event date).
Transfer out of an ICU was assessed among those participants who had initiated linezolid or vancomycin therapy in the ICU.
|
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
|
Time to Intubation
大体时间:Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).
|
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
|
Time to 30-day Re-admission
大体时间:Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.
|
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
|
Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection
大体时间:Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge.
|
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
|
Clinical Success
大体时间:Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
Clinical success, a composite outcome defined as discharge from the hospital or ICU by day 14 after treatment initiation, in the absence of death, therapy change, or intubation by day 14.
Percentage of participants with clinical success was reported.
|
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年12月1日
初级完成 (实际的)
2013年1月1日
研究完成 (实际的)
2013年1月1日
研究注册日期
首次提交
2013年2月28日
首先提交符合 QC 标准的
2013年3月22日
首次发布 (估计)
2013年3月28日
研究记录更新
最后更新发布 (估计)
2014年1月30日
上次提交的符合 QC 标准的更新
2013年12月12日
最后验证
2013年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.