Epidemiology and Current Practices in Severe Community-Acquired Pneumonia

NCT07301099 | Not Yet Recruiting

• 2 other identifiers: Acta No. 690 10-Oct-202520251004
• Study Type: observational
• Target: 2,588
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Community-acquired Pneumonia (sCAP)

Keywords

Pneumonia; Respiratory Tract Infections; Community-Acquired Pneumonia; Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (2)

• 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.

  From hospital admission to hospital discharge (up to 30 days)

• 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.

  During the index hospitalisation (up to 30 days)

Secondary Outcomes (7)

• 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)

Study Arms (1)

Adult patients with Severe Community-Acquired Pneumonia (sCAP)

Clinical follow-up for 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de la Sabana: lead
• International Severe Acute Respiratory and Emerging Infection Consortium: collaborator
• European Society of Intensive Care Medicine: collaborator
• Latin American Intensive Care Network (LIVEN): collaborator

Study Sites (1)

Clínica Universidad de La Sabana

Chía, Colombia

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Lower respiratory tract sample (either sputum or endotracheal aspirates) for conventional culture, multiplex PCR testing (virus and/or bacterial detection) * Blood and urine samples

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Lung Diseases

Study Officials

• Luis Felipe Reyes, MD, MSc, PhD

  Universidad de la Sabana

  PRINCIPAL INVESTIGATOR

• Ignacio-Martin Loeches, MD, PhD, FJFICMI

  St James's Hospital, Trinity College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Felipe Reyes, MD, MSc, PhD

CONTACT

+57 3175130128; luis.reyes5@unisabana.edu.co

Lina Martinez-L, MD

CONTACT

+57 3015375128; linamarle@unisabana.edu.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 24, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

CO (1)