Epidemiology and Current Practices in Severe Community-Acquired Pneumonia (PLENITUDE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,588
- 试验地点
- 1
- 主要终点
- All-Cause In-Hospital Mortality
研究概览
简要总结
The goal of this observational study is to learn more about severe community-acquired pneumonia (sCAP) in adults who need hospital or intensive care. This type of pneumonia starts outside the hospital and can quickly become life-threatening. The study aims to understand how people with sCAP are cared for in different parts of the world and how these differences relate to their recovery.
- The main questions this study aims to answer are:
- What are the characteristics, treatments, and outcomes of adults with sCAP?
- How closely do hospitals follow international guidelines for diagnosing and treating sCAP?
- What factors are linked to worse outcomes, such as the need for a ventilator or risk of death?
This study will not test any new drugs or procedures. Instead, researchers will observe the care that participants already receive as part of their normal treatment. Hospitals in many countries will take part, including centres in Europe, North America, Latin America, Asia, Africa, and Oceania. This global participation will help show how sCAP affects people in different health systems and communities.
Participants will be adults who arrive at a hospital or intensive care unit with severe pneumonia. Most information will come from medical records, such as symptoms, test results, treatments given, and how participants respond to care. In some hospitals with special laboratory capacity, additional blood or breathing samples may be collected to study how the body fights infection.
No extra visits are required for routine data-only participants. In sites that collect samples, these will usually be taken at the same time as routine medical care to avoid extra procedures. Researchers will also ask about recovery after hospital discharge at 60 days, 6 months, and 12 months. These follow-ups will help us understand long-term health, complications, and quality of life after sCAP.
By collecting information from a large number of hospitals around the world, this study hopes to identify patterns that can help improve diagnosis, treatment, and survival for people with severe pneumonia. The findings may also help health care teams and public health leaders update treatment guidelines and strengthen care for future patients.
详细描述
Severe community-acquired pneumonia (sCAP) is a life-threatening infection requiring hospital or ICU care. Mortality remains high, and there are major differences worldwide in diagnosis, treatment practices, and availability of resources. Although new international guidelines exist, real-world implementation is not well understood. The PLENITUDE study is a multinational, prospective observational cohort designed to describe global practices, outcomes, microbiology, and biological responses in adults with sCAP using a harmonized research framework.
The study uses a tiered approach aligned with the ISARIC/WHO Clinical Characterisation Protocol. Tier 0 sites collect standardized clinical data from routine medical records. Tier 1 sites also collect a single set of biological samples at admission. Tier 2 sites perform serial biological sampling to evaluate pathogen dynamics and host immune responses over time. This structure allows participation from hospitals with varying levels of resources while preserving core standardization.
Data are collected using variables derived from the ISARIC ARC library to ensure consistency across regions. Clinical information includes demographics, comorbidities, illness severity, laboratory and imaging results, respiratory support, microbiology, treatments, complications, and outcomes. All data are entered into a secure REDCap platform with automated validation rules, range checks, and logic checks. Participant confidentiality is maintained through unique study identifiers and restricted access for authorized personnel.
Quality assurance procedures include programmed data validation, periodic monitoring of completeness and protocol adherence, and selective source data verification. Standard Operating Procedures guide patient identification, sample handling, data entry, and reporting of deviations. Site teams receive training in protocol operations and data management.
Tier 1 and Tier 2 samples follow standardized processing steps based on the ISARIC/WHO CCP, including centrifugation, aliquoting, freezing, and safe handling according to biosafety requirements. Regional laboratory hubs support advanced analyses such as molecular pathogen detection, sequencing, and immune response profiling, improving comparability and quality control across participating countries.
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
- •Adults aged 18 years or older are hospitalised with a clinical diagnosis of sCAP according to the American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) criteria.16
- •Admission to participating hospitals or ICUs during the study period.
- •Provision of informed consent by the patient or legally authorised representative for those centres collecting biological samples. Data-only participants will not be required to sign informed consent.
排除标准
- •Paediatric population (<18 years old)
- •Pneumonia acquired in the hospital setting (i.e., nosocomial or hospital-acquired pneumonia).
- •Insufficient clinical information to confirm the diagnosis of sCAP.
- •Immunosuppression: i.e. Active cancer, hematopoietic cell transplant, solid organ transplant recipients, HIV diagnosed patients regardless of CD4 cell count, chronic immunosuppression with corticosteroids, inborn errors of immunity.
研究组 & 干预措施
Adult patients with Severe Community-Acquired Pneumonia (sCAP)
Clinical follow-up for 12 months
结局指标
主要结局
All-Cause In-Hospital Mortality
时间窗: From hospital admission to hospital discharge (up to 30 days)
Proportion of enrolled adult patients with severe community-acquired pneumonia (sCAP) who die from any cause during the index hospitalisation. Mortality status will be abstracted from clinical and administrative records at ICU and hospital discharge. This measure describes the severity and outcomes of sCAP across diverse international healthcare settings.
Adherence to International sCAP Management Guidelines
时间窗: During the index hospitalisation (up to 30 days)
Percentage of adherence to the ERS/ESICM/ESCMID/ALAT guidelines for the management of severe community-acquired pneumonia. Adherence will be quantified using predefined key indicators related to diagnostic evaluation, antibiotic initiation, ventilatory support, biomarker use, ICU management and follow-up practices. This measure evaluates real-world implementation of guideline-based care across participating centres.
次要结局
- ICU Mortality(From ICU admission to ICU discharge (up to 30 days))
- 60-Day and 180-Day Mortality(60 days and 180 days after enrolment)
- Length of Hospital Stay(From hospital admission to discharge (up to 30 days))
- Duration of Mechanical Ventilation(During the index hospitalisation (up to 30 days))
- Occurrence of Major Complications(During the index hospitalisation (up to 30 days))
- ICU or Hospital Readmission(60 days and 180 days after discharge)
- Health-Related Quality of Life (HRQoL)(At hospital discharge (assessed up to 90 days from admission), and at 12 months (±30 days) following hospital discharge.)