NCT01879761进行中（未招募）不适用
Immune Resolution After Staphylococcus Aureus Bacteremia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- HLA-DR and cytokines
研究概览
简要总结
The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in patients with and without prior immune dysfunction who survive sepsis from Staphylococcus aureus bacteremia.
We hypothesize that patients with prior immune dysfunction will have greater reductions in HLA-DR and other markers of immune function after an episode of sepsis than people who do not have prior immune dysfunction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •At least one blood culture positive for S. aureus
- •Patients aged ≥18 years
- •At least two of four systemic inflammatory response syndrome (SIRS) criteria on the day of positive blood cultures. SIRS criteria are:
- •Body temperature less than 36°C(96.8°F) or greater than 38°C(100.4°F)
- •Heart rate greater than 90 beats per minute
- •Tachypnea (high respiratory rate), with greater than 20 breaths per minute; or, an arterial partial pressure of carbon dioxide less than 32 mmHg
- •WBC less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L); or the presence of greater than 10% immature neutrophils (band forms)
排除标准
- •Sequential Organ Failure Assessment (SOFA) score > 12 on day of positive blood cultures
- •Survival expected to be < 7 days from positive blood cultures
研究组 & 干预措施
Immunosuppressed
Immunosuppressed includes patients with any one of the following:
- a diagnosis of a hematological malignancy
- a diagnosis of HIV
- myelosuppressive chemotherapy in the previous 90 days
- immune-modulating medications in the previous 90 days
Non-Immunosuppressed
Subject does not fit immunosuppressed criteria
结局指标
主要结局
HLA-DR and cytokines
时间窗: 0-30 days
Percent expression of HLA-DR on monocytes will be measured by flow cytometry. Cytokine levels will be measured by ELISA.
次要结局
- New Infections(0-90 days)
研究者
研究点 (2)
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