Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- 28-day ICU mortality
研究概览
简要总结
the investigators aim to set up a multicenter registry study for severe PJP requiring ICU admission. The purpose of this study is
- to establish a prospective severe PJP registry about clinical characteristics, laboratory and radiographic findings, critical care management and outcomes.
- to explore the predictive factors associated with outcomes ;
- to compare the difference between PJP patients with HIV and without HIV infection.
详细描述
Pneumocystis jiroveci pneumonia (PJP) is a common opportunistic infection in immunocompromised patients. Although the mortality of patients with mild to moderate PJP has declined substantially, the reported outcomes of severe PJP requiring ICU admission, especially with mechanical ventilation are grave. The data on this group of patients is very limited and mainly comes from retrospective studies.
the investigators aim to set up a multicenter registry study for patient with severe PJP requiring ICU admission to provide comprehensive descriptive data on diagnosis, clinical course, critical care management and outcomes in a large cohort.
All patients with PJP admitted to the participating ICU during a two-year period will be enrolled. The CRF will be made available to the participating sites as a printable paper-based CRF.
The following individual patient data for study participants will be collected:
- General demographic information
- Presence of risk factors for PJP and comorbid condition
- use of prophylactic SMZ/TMP, immunosuppressive medications prior to ICU admission
- Information about PJP and co-infection diagnosis
- vital signs, laboratory(blood serum and BALF sample) and radiologic data at ICU admission and during ICU stay
- organ failures and severity of the disease at admission, new onset of organ failures during ICU stay
- Medications for PJP, time course and modalities and settings for respiratory support
- ICU, 28-day mortality, hospital, 90-day mortality
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
- •diagnosis with PJP, confirmed by PCR or methenamine silver stain of sample from BALF, aspirate or sputum;
- •ICU admission due to PJP-related respiratory failure
排除标准
- 未提供
结局指标
主要结局
28-day ICU mortality
时间窗: Day 28
28 days mortality after ICU admission
次要结局
- ICU length of stay(Day 90)
- occurrence of pneumothorax or pneumomediastinum(day 28)
- mechanical ventilation free days(day 28)
- hospital mortality(Day 90 (censored at hospital discharge if discharge prior to Day 90))
- hospital length of stay(Day 90)
- occurrence of SMZ/TMP treatment failure(day 7 after SMZ/TMP treatment)
- occurrence of non-invasive mechanical ventilation(day 28)
- ICU acquired infectious disease(day 28)