Epidemiology and Current Practices in Severe Community-Acquired Pneumonia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversidad de la Sabana
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
This study will enrol adult patients presenting with severe community-acquired pneumonia (sCAP) at participating hospitals and intensive care units worldwide. Participants will be identified through routine clinical care upon hospital or ICU admission. The study includes centres across Europe, North America, Latin America, Asia, Africa, and Oceania, ensuring broad geographical and healthcare system representation. Data-only participants will be sourced from electronic medical records, while biological samples will be collected in Tier 1 and Tier 2 sites with laboratory capacity. The multinational design allows inclusion of patients from high-, middle-, and low-income countries, supporting a diverse and globally representative cohort.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,588 Participants
are grouped into 1 trial groupGroup A: Adult patients with Severe Community-Acquired Pneumonia (sCAP)
Trial outcomes
Primary outcomes
1
All-Cause In-Hospital Mortality
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.
Time frame
From hospital admission to hospital discharge (up to 30 days)2
Adherence to International sCAP Management Guidelines
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.
Time frame
During the index hospitalisation (up to 30 days)Secondary outcomes
1
ICU Mortality
Proportion of patients with sCAP who die during the ICU stay. Mortality status will be obtained from clinical and administrative records. This outcome allows comparison of mortality patterns across regions and centres and contributes to understanding the severity and progression of sCAP within critical care settings.
Time frame
From ICU admission to ICU discharge (up to 30 days)2
60-Day and 180-Day Mortality
Proportion of enrolled patients who die within 60 and 180 days after hospital admission. Mortality will be assessed through clinical records, follow-up contacts, and post-discharge documentation. This outcome characterises mid- and long-term survival trajectories in patients who experience sCAP.
Time frame
60 days and 180 days after enrolment3
Length of Hospital Stay
Number of days from hospital admission to discharge or death. This measure reflects clinical severity, resource utilisation, and recovery trajectory across diverse healthcare settings.
Time frame
From hospital admission to discharge (up to 30 days)4
Duration of Mechanical Ventilation
Total duration (in days) of invasive or non-invasive mechanical ventilation among patients requiring respiratory support. This outcome provides insight into respiratory failure severity and treatment practices across participating ICUs.
Time frame
During the index hospitalisation (up to 30 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad de la Sabana
Lead sponsor
International Severe Acute Respiratory and Emerging Infection Consortium
Collaborator
European Society of Intensive Care Medicine
Collaborator
Latin American Intensive Care Network (LIVEN)
Collaborator
Source ClinicalTrials.gov
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