Community-acquired Pneumonia in Immunosuppressed Adult Patients: Observational, Perspective Study, ItAlian ReGistry Of pNeumoniA in immUnocompromised paTients (ARGONAUT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,298
- 试验地点
- 1
- 主要终点
- In-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.
研究概览
简要总结
This multicentric, prospective study aims at:
evaluating the prevalence, etiology, characteristics, and 1one-year outcomes of immunocompromised patients hospitalized for Community-Acquired Pneumonia (CAP); conducting biochemical, microbiological and genetic analysis on collected samples.
详细描述
Primary endpoint:
Collection of in- hospitalisation mortality for all causes in immunocompromised patients with CAP enrolled.
Secondary endpoints:
Collection of data on admission and during hospitalisation to evaluate clinical response to empirical treatments (including antibiotic therapy) related to severity of disease and microbiological etiology.
Prevalence of cardiovascular events and all-cause mortality during hospitalization or after discharge.
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
- •Hospitalized patients with a confirmed diagnosis of Community-Acquired Pneumonia (CAP) characterized by at least one of the following risk factors for immunosuppression:
- •Aplastic anemia;
- •Asplenia;
- •Hematologic malignancy (e.g., lymphoma/acute or chronic myeloid leukemia/multiple myeloma);
- •Chemotherapy within the last 3 months;
- •Neutropenia defined as a white blood cell count less than 500/dL on a complete blood count;
- •Use of biologics (including trastuzumab and therapy for autoimmune diseases (e.g., anti-TNF α), prescribed within the last 6 months before hospital admission;
- •Solid organ transplant;
- •Bone marrow transplant;
- •Chronic oral steroid use (>10 mg/day prednisone or equivalent ≥3 months before accessing the ED, or cumulative dose > 600 mg prednisone);
- •Use of corticosteroid therapy with a dose ≥ 20 mg prednisone or equivalent ≥14 days or cumulative dose > 600 mg prednisone;
- •Active malignancy;
- •Malignancy within one year of pneumonia (excluding patients with localized skin cancer or early-stage malignancy);
- •Lung malignancy with neutropenia/chemotherapy;
- •Other solid malignancy with neutropenia/chemotherapy;
- •Other immunodeficiency (including congenital/genetic immunosuppression and immunosuppressive therapy secondary to hematologic malignancy or solid malignancy);
- •Primary immunodeficiency.
排除标准
- 未提供
结局指标
主要结局
In-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.
时间窗: During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average)
Recording in-hospital mortality for all causes in immunocompromised patients with CAP enrolled in the study.
次要结局
- Subsequent re-admission within 1 year(Within 365 days after hospital discharge)
- Time to clinical stability(DAY 1 to 8)
- Mortality for all causes in immunocompromised patients with CAP(30 days, 3 months, 6 months and 12 months after hospital discharge.)
- New hospitalizations in immunocompromised patients with CAP.(30 days, 3 months, 6 months and 12 months after hospital discharge.)
- Prevalence of cardiovascular events in immunocompromised patients with CAP.(30 days, 3 months, 6 months and 12 months after hospital discharge.)
- Length of hospital stay (days)(Through hospital discharge, ranging from 1 day to 2 weeks)
- Need for mechanical ventilation %(During hospitalization (1 day to 2 weeks on average))
- ICU admission %(During hospitalization corresponding to study enrollment (1 day to 2 weeks of hospitalization on average))
- Lenght of mechanical ventilation (Hours)(During hospitalization (1 day to 2 weeks on average))
- Rate of antibiotic therapy modification (%)(During hospitalization (1 day to 2 weeks on average))
- Characterization of Microbiological Etiology Using 16S rRNA Sequencing and Whole-Genome Sequencing(Through study completion, for up to 4 years)