NCT06126263进行中（未招募）不适用
Comparative Effectiveness of Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections: A Target Trial Emulation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- In hospital mortality or discharge to hospice
研究概览
简要总结
This study aims to emulate a hypothetical target pragmatic multi-center, non-blinded trial of adult inpatients in the PINC AITM dataset with B-lactam treated culture confirmed monomicrobial invasive Group A streptococcus (GAS) between the years 2015-2021
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult inpatients patients (=> 18 y of age)
- •Monomicrobial Group A streptococcus invasive infection
- •Primary therapy with a B-lactam agent (initiated before or on same day as adjunctive anti-toxin therapy)
排除标准
- •Patients with a polymicrobial GAS culture (non-GAS organisms identified on eligibility GAS culture)
- •Patients who received linezolid but have a documented linezolid resistant isolate
- •Patients with GAS infections of non-sterile non-invasive sites (i.e sites which do not meet above mentioned inclusion criteria) which include but not limited to the lower urinary tract, upper respiratory tract
- •Patient with concomitant MSSA/MRSA invasive infection (+/- seven days of index GAS eligibility culture)
- •Patients who receive both anti-toxin agents (violation of protocol)
- •Patient who do not complete at least 3 days of B-lactam (violation of protocol)
结局指标
主要结局
In hospital mortality or discharge to hospice
时间窗: Hospital stay
In hospital mortality or discharge to hospice
次要结局
- Length of stay among survivors(Hospital stay)
- Clostridioides difficile infection(Within hospital stay of interest)
研究者
Sameer Kadri, M.D.
Tenure Track Investigator
National Institutes of Health Clinical Center (CC)
研究点 (1)
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