Severe Community-acquired Pneumonia (sCAP)PLENITUDENCT07301099
Epidemiology and Current Practices in Severe Community-Acquired Pneumonia
An observational study of Severe Community-acquired Pneumonia (sCAP), run by Universidad de la Sabana at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Community-acquired Pneumonia (sCAP)
- How many people
- 2,588 participants
- Where
- 1 siteColombia
- Study dates
- 1 Feb 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Clínica Universidad de La Sabana
Chía
Luis Felipe Reyes, MD, MSc, PhD, +57 3175130128, luis.reyes5@unisabana.edu.co
Lina Martinez-L, MD, linamarle@unisabana.edu.co
About this study
Official title: Epidemiology and Current Practices in Severe Community-Acquired Pneumonia (PLENITUDE)
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?
Read more
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.
Read the detailed description
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.
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.
- Keywords
- Pneumonia, Respiratory Tract Infections, Community-Acquired Pneumonia, Respiratory Tract Diseases
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia, Respiratory Tract Infections, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with Severe Community-Acquired Pneumonia (sCAP) | Clinical follow-up for 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the index hospitalisation (up to 30 days)
Secondary outcomes (7)
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.
Measured: From ICU admission to ICU discharge (up to 30 days)
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.
Measured: 60 days and 180 days after enrolment
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.
Measured: From hospital admission to discharge (up to 30 days)
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.
Measured: During the index hospitalisation (up to 30 days)
Occurrence of Major Complications
Proportion of patients experiencing complications such as septic shock, ARDS, secondary infections, or multi-organ failure during hospitalisation. Complications will be identified using predefined clinical criteria abstracted from medical records.
Measured: During the index hospitalisation (up to 30 days)
ICU or Hospital Readmission
Proportion of patients readmitted to the ICU or hospital within 60 or 180 days after discharge. Readmissions will be assessed through clinical documentation, follow-up visits, and contact with participants or family members.
Measured: 60 days and 180 days after discharge
Health-Related Quality of Life (HRQoL)
Assessment of Health-Related Quality of Life (HRQoL) using the validated EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) at the day of hospital discharge and during follow-up evaluation at 12 months post-discharge. This outcome aims to quantify long-term functional recovery and wellbeing after severe community-acquired pneumonia (sCAP).
Measured: At hospital discharge (assessed up to 90 days from admission), and at 12 months (±30 days) following hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Community-acquired Pneumonia (sCAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Collaborators
- International Severe Acute Respiratory and Emerging Infection Consortium, European Society of Intensive Care Medicine, Latin American Intensive Care Network (LIVEN)
- Responsible party
- Sponsor
- Investigators
- Luis Felipe Reyes, MD, MSc, PhD, Principal investigator, Universidad de la SabanaIgnacio-Martin Loeches, MD, PhD, FJFICMI, Principal investigator, St James's Hospital, Trinity College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301099
- Sponsor's protocol ID
- Acta No. 690 10-Oct-2025
- Other IDs
- 20251004
- Acronym
- PLENITUDE
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding the sharing of individual participant data has not yet been finalized. IPD availability will depend on ethical approvals, institutional policies, and data-governance requirements across participating sites.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Current Practices in Severe Community-Acquired Pneumonia (PLENITUDE)
- ClinicalTrials.gov ID
- NCT07301099
- Acronym / sponsor ID
- PLENITUDE / Acta No. 690 10-Oct-2025
- Keywords
- Pneumonia, Respiratory Tract Infections, Community-Acquired Pneumonia, Respiratory Tract Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,588 participants (estimated)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Collaborators
- International Severe Acute Respiratory and Emerging Infection Consortium, European Society of Intensive Care Medicine, Latin American Intensive Care Network (LIVEN)
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with Severe Community-Acquired Pneumonia (sCAP) | – | –Clinical follow-up for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-Cause In-Hospital Mortality
Time frame: 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
Time frame: 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.
7 secondary outcomes
ICU Mortality
Time frame: From ICU admission to ICU discharge (up to 30 days)
60-Day and 180-Day Mortality
Time frame: 60 days and 180 days after enrolment
Length of Hospital Stay
Time frame: From hospital admission to discharge (up to 30 days)
Duration of Mechanical Ventilation
Time frame: During the index hospitalisation (up to 30 days)
Occurrence of Major Complications
Time frame: During the index hospitalisation (up to 30 days)
ICU or Hospital Readmission
Time frame: 60 days and 180 days after discharge
Health-Related Quality of Life (HRQoL)
Time frame: At hospital discharge (assessed up to 90 days from admission), and at 12 months (±30 days) following hospital discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided. The decision regarding the sharing of individual participant data has not yet been finalized. IPD availability will depend on ethical approvals, institutional policies, and data-governance requirements across participating sites.
Related trials for Severe Community-acquired Pneumonia (sCAP)
RecruitingPhase 3
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
Community-acquired Pneumonia
Enrolling by invitationObservational study
ESCAPE10: Epidemiology, Risk Factors, and Outcomes of Severe Community-acquired Pneumonia in Elderly Patients Acquired Pneumonia in Elderly Patients
Severe Community-Acquired Pneumonia (sCAP), Elderly Infection
Not yet recruitingPhase 2/3
Randomized Adaptive Platform Trial of Pathogen-Directed Anti-inflammatory Therapy in Severe Community-Acquired Pneumonia(Core Protocal)
Severe Community-acquired Pneumonia (sCAP)
Not yet recruiting
Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in South Korea
Severe Community-acquired Pneumonia (sCAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis Felipe Reyes, MD, MSc, PhD principal investigator
Universidad de la Sabana
Ignacio-Martin Loeches, MD, PhD, FJFICMI principal investigator
St James's Hospital, Trinity College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Community-acquired Pneumonia (sCAP), run by Universidad de la Sabana at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Felipe Reyes, MD, MSc, PhD (+57 3175130128, luis.reyes5@unisabana.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause In-Hospital Mortality (time frame: From hospital admission to hospital discharge (up to 30 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.