Epidemiology and Current Practices in Severe Community-Acquired Pneumonia
NCT ID: NCT07301099
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
2588 participants
OBSERVATIONAL
2026-02-01
2027-08-31
Brief Summary
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* 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.
Detailed Description
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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.
The statistical analysis plan includes descriptive summaries of clinical presentation and management, comparative analyses across regions or guideline adherence groups, multivariable models for risk factor identification, time-to-event analyses, and mixed-effects models for repeated measures in Tier 2. Unsupervised clustering will be used to explore phenotypes and endotypes. Missing data will be addressed using multiple imputation and sensitivity analyses.
Participants are followed during hospitalization and after discharge at 60 days, 6 months, and 12 months to evaluate long-term outcomes, readmissions, persistent symptoms, and quality of life. Follow-up methods include record review and phone or electronic assessments, depending on site capability.
The study is overseen by international Principal Investigators, a Steering Committee of experts, and a centralized data management team. PLENITUDE is expected to generate real-world evidence on global sCAP management, guideline adherence, microbial and immune patterns, and long-term outcomes. These findings may inform improvements in clinical care, strengthen public health strategies, and support future advances in precision medicine for severe pneumonia.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adult patients with Severe Community-Acquired Pneumonia (sCAP)
Clinical follow-up for 12 months
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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International Severe Acute Respiratory and Emerging Infection Consortium
OTHER
European Society of Intensive Care Medicine
OTHER
Latin American Intensive Care Network (LIVEN)
UNKNOWN
Universidad de la Sabana
OTHER
Responsible Party
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Principal Investigators
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Luis Felipe Reyes, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de la Sabana
Ignacio-Martin Loeches, MD, PhD, FJFICMI
Role: PRINCIPAL_INVESTIGATOR
St James's Hospital, Trinity College Dublin
Locations
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Clínica Universidad de La Sabana
Chía, , Colombia
Countries
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Central Contacts
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Luis Felipe Reyes Velasco, MD, MSc, PhD
Role: CONTACT
Phone: +57 3175130128
Email: [email protected]
Facility Contacts
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Luis Felipe Reyes Velasco, MD, MSc, PhD
Role: primary
Lina Martinez-L, MD
Role: backup
Other Identifiers
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20251004
Identifier Type: OTHER
Identifier Source: secondary_id
Acta No. 690 10-Oct-2025
Identifier Type: -
Identifier Source: org_study_id