Community Acquired Pneumonia (CAP)Pneumonia-1NCT07011433
Pneumonia Pathogens' Virulence Factors, Patient Inflammatory Markers, and Their Associations With Outcomes
An observational study of Community Acquired Pneumonia (CAP) and Hospital Acquired Pneumonia, run by Ruta Nutautiene at 1 site in Lithuania.
Trial summary
The study aims to evaluate pneumonia symptoms using physical examinations, radiological and laboratory tests, and prognostic scales such as the Pneumonia Severity Index (PSI) and CURB65. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia (CAP), Hospital Acquired Pneumonia
- What is being tested?
- Inflammatory Biomarker Evaluation
- How many people
- 300 participants
- Where
- 1 siteLithuania
- Study dates
- 2 Apr 2024to 2 Jan 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: Adult hospitalized patients diagnosed with community-acquired or hospital-acquired pneumonia who meet the inclusion criteria and consent to participate in the study.
Who may be able to join
- Age ≥18 years;
- Diagnosed with community-acquired or hospital-acquired pneumonia;
- Provides written informed consent.
Who cannot join
- Age under 18;
- Inability to provide informed consent;
- Patients with autoimmune diseases;
- Patients with chronic lung diseases such as cystic fibrosis or COPD;
- Contraindications to venipuncture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site
Department of Laboratory Medicine, Lithuanian University of Health Sciences
Kaunas, 44307
About this study
Official title: Prognostic Value of Pneumonia Pathogens' Virulence Factors and Patient Inflammatory Markers, and Their Associations With Disease Course and Outcome
The study aims to evaluate pneumonia symptoms using physical examinations, radiological and laboratory tests, and prognostic scales such as the Pneumonia Severity Index (PSI) and CURB65. These methods will be combined with the assessment of biomarkers and inflammatory cytokines to enhance clinical decision-making and predict adverse outcomes. Procalcitonin (PCT) levels will help guide the initiation and duration of antibiotic therapy, while variations in treatment may be based on initial levels of inflammatory biomarkers. A notable focus is placed on the CD64 marker, which can increase significantly under the influence of pro-inflammatory cytokines (IL-6, G-CSF) within hours and return to baseline as the infection subsides.
Microbiological testing will be performed selectively, particularly when results could affect antimicrobial therapy choices. Sputum microscopy is planned before antibiotic prescription, with only high-quality samples being considered. Poor-quality sputum will not be further tested. Invasive diagnostic methods will be used only as specified by pneumonia treatment protocols. Bronchoscopy, including bronchoalveolar lavage (BAL), is reserved for severe pneumonia cases under specific conditions, such as failure to expectorate sputum, multiple Gram-negative or fungal isolates, or poor treatment response.
Radiological diagnostics will include chest X-rays in anteroposterior and lateral views, as infiltrates in certain lung segments may be missed on single views. Early radiographic findings may reveal only subtle changes in the lung pattern, so follow-up imaging is planned to ensure an accurate diagnosis. The study will be conducted exclusively in specialized hospital units to maintain patient safety. The collected data will allow for the analysis of relationships between pathogens, their virulence, immune responses, and disease outcomes.
Read the detailed description
The study will assess pneumonia symptoms based on physical examination and additional data (radiological or laboratory tests), supported by prognostic scales such as the Pneumonia Severity Index (PSI), CURB65 (Annexes No. 7 and 8), in combination with biomarkers and inflammatory cytokines. This approach aims to improve decision-making and predict poor outcomes. In the process of lower respiratory tract infections, the level of procalcitonin (PCT) is intended to guide both the initiation and duration of antibiotic therapy. Additionally, treatment may vary depending on the initial levels of inflammatory biomarkers. Under the influence of pro-inflammatory cytokines (IL-6, G-CSF), CD64 can increase more than tenfold within 4-6 hours. Normally, CD64 expression is low, but it significantly increases within hours when activated by infection. Once the activation subsides, CD64 expression returns to baseline levels within a few days. The summarized data will show correlations between pathogens, their virulence factors, the patient's immune response, and disease outcomes.
Microbiological testing will be conducted when results could influence antimicrobial therapy selection. Sputum microscopy is planned before prescribing antibacterial treatment. Only good-quality sputum samples will be considered for accurate diagnosis. If microscopy reveals poor-quality sputum, further testing will not be pursued. Invasive methods for determining the etiology are intended to be used only when required by pneumonia diagnostic and treatment protocols. The study is planned to be conducted exclusively in specialized hospital units that ensure patient safety. Bronchoscopy, including bronchoalveolar lavage (BAL), is indicated in cases of severe pneumonia and at least one of the following conditions:
- inability to expectorate sputum;
- absence of predominant potential pathogens in sputum culture;
- inadequate response to treatment based on susceptibility of the isolated pathogen;
- isolation of multiple types of Gram-negative rods or fungi in sputum culture;
- suspected superinfection.
In all cases of pneumonia diagnosis, chest X-rays (anteroposterior and/or lateral views) are planned. Infiltrates located in the 2nd, 6th, 9th, and 10th segments may not be visible on the anteroposterior view alone. On the first day of illness, only local changes in the lung pattern-caused by hyperemia, perivascular and peribronchial edema, and infiltration-may be seen. Therefore, chest radiographic examination is planned to be repeated.
- Being tested
- Inflammatory Biomarker Evaluation
- Keywords
- Community-Acquired Pneumonia, Inflammatory Biomarkers, Immune response, Bronchoalveolar Lavage, Procalcitonin
- Medical subject headings
- Community-Acquired Pneumonia, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammatory Biomarker EvaluationDiagnostic test
Venous blood samples are collected from subjects and analyzed for inflammatory biomarkers, including CD64, presepsin, IL-6, and IL-8, using a Luminex multiplex assay. Results are used for research purposes only and do not affect clinical management.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | Participants receive standard pneumonia diagnostics and treatment according to national clinical guidelines, without additional evaluation of immune response biomarkers. Receives: Diagnostic Test: Inflammatory Biomarker Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between inflammatory biomarkers and ICU admission rates
Measurement of serum levels of CD64 (index), presepsin (pg/ml), and IL-6 (pg/ml) using a Luminex multiplex assay in patients with community-acquired or hospital-acquired pneumonia and evaluation of their correlation with ICU admission (Incidence of cases/100000 inhabitants).
Measured: Up to 30 days from enrollment
Correlation between inflammatory biomarkers and hospitalization length
Measurement of serum levels of CD64 (index), presepsin (pg/ml), and IL-6 (pg/ml) using a Luminex multiplex assay in patients with community-acquired or hospital-acquired pneumonia and evaluation of their correlation with hospitalization (days).
Measured: Up to 30 days from enrollment
Correlation between inflammatory markers and a 30-day mortality rate
Measurement of serum levels of CD64 (index), presepsin (pg/ml), and IL-6 (pg/ml) using a Luminex multiplex assay in patients with community-acquired or hospital-acquired pneumonia and evaluation of their correlation with 30 day mortality rates (Incidence of cases / 100000 inhabitants)
Measured: Up to 30 days from enrollment
Secondary outcomes (2)
Measurement of CD64 expression
Measurement of serum levels of CD64 (index).
Measured: Within 30 days of enrollment
Measurement of inflammatory biomarkers
Measurement of serum levels of presepsin (pg/ml), and IL-6 (pg/ml) in patients
Measured: Within 30 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start2 Apr 2024
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired Pneumonia (CAP)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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruta Nutautiene
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruta Nutautiene, Lithuanian University of Health Sciences
- Investigators
- Astra Vitkauskiene, prof. dr., MD, PhD, Study director, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011433
- Sponsor's protocol ID
- 2024-BE10-0003
- Acronym
- Pneumonia-1
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including all IPD collected throughout the trial, clinical and biomarker results, will be made available upon reasonable request for scientific research purposes, only IPD used in the results publication. Data will be shared under data use agreements that ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Pneumonia Pathogens' Virulence Factors and Patient Inflammatory Markers, and Their Associations With Disease Course and Outcome
- ClinicalTrials.gov ID
- NCT07011433
- Acronym / sponsor ID
- Pneumonia-1 / 2024-BE10-0003
- Keywords
- Community-Acquired Pneumonia, Inflammatory Biomarkers, Immune response, Bronchoalveolar Lavage, Procalcitonin
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ruta NutautieneUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 8 Jun 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 study aims to evaluate pneumonia symptoms using physical examinations, radiological and laboratory tests, and prognostic scales such as the Pneumonia Severity Index (PSI) and CURB65. These methods will be combined with the assessment of biomarkers and inflammatory cytokines to enhance clinical decision-making and predict adverse outcomes. Procalcitonin (PCT) levels will help guide the initiation and duration of antibiotic therapy, while variations in treatment may be based on initial levels of inflammatory biomarkers. A notable focus is placed on the CD64 marker, which can increase significantly under the influence of pro-inflammatory cytokines (IL-6, G-CSF) within hours and return to baseline as the infection subsides.
Microbiological testing will be performed selectively, particularly when results could affect antimicrobial therapy choices. Sputum microscopy is planned before antibiotic prescription, with only high-quality samples being considered. Poor-quality sputum will not be further tested. Invasive diagnostic methods will be used only as specified by pneumonia treatment protocols. Bronchoscopy, including bronchoalveolar lavage (BAL), is reserved for severe pneumonia cases under specific conditions, such as failure to expectorate sputum, multiple Gram-negative or fungal isolates, or poor treatment response.
Radiological diagnostics will include chest X-rays in anteroposterior and lateral views, as infiltrates in certain lung segments may be missed on single views. Early radiographic findings may reveal only subtle changes in the lung pattern, so follow-up imaging is planned to ensure an accurate diagnosis. The study will be conducted exclusively in specialized hospital units to maintain patient safety. The collected data will allow for the analysis of relationships between pathogens, their virulence, immune responses, and disease outcomes.
Detailed description
The study will assess pneumonia symptoms based on physical examination and additional data (radiological or laboratory tests), supported by prognostic scales such as the Pneumonia Severity Index (PSI), CURB65 (Annexes No. 7 and 8), in combination with biomarkers and inflammatory cytokines. This approach aims to improve decision-making and predict poor outcomes. In the process of lower respiratory tract infections, the level of procalcitonin (PCT) is intended to guide both the initiation and duration of antibiotic therapy. Additionally, treatment may vary depending on the initial levels of inflammatory biomarkers. Under the influence of pro-inflammatory cytokines (IL-6, G-CSF), CD64 can increase more than tenfold within 4-6 hours. Normally, CD64 expression is low, but it significantly increases within hours when activated by infection. Once the activation subsides, CD64 expression returns to baseline levels within a few days. The summarized data will show correlations between pathogens, their virulence factors, the patient's immune response, and disease outcomes.
Microbiological testing will be conducted when results could influence antimicrobial therapy selection. Sputum microscopy is planned before prescribing antibacterial treatment. Only good-quality sputum samples will be considered for accurate diagnosis. If microscopy reveals poor-quality sputum, further testing will not be pursued. Invasive methods for determining the etiology are intended to be used only when required by pneumonia diagnostic and treatment protocols. The study is planned to be conducted exclusively in specialized hospital units that ensure patient safety. Bronchoscopy, including bronchoalveolar lavage (BAL), is indicated in cases of severe pneumonia and at least one of the following conditions:
- inability to expectorate sputum;
- absence of predominant potential pathogens in sputum culture;
- inadequate response to treatment based on susceptibility of the isolated pathogen;
- isolation of multiple types of Gram-negative rods or fungi in sputum culture;
- suspected superinfection.
In all cases of pneumonia diagnosis, chest X-rays (anteroposterior and/or lateral views) are planned. Infiltrates located in the 2nd, 6th, 9th, and 10th segments may not be visible on the anteroposterior view alone. On the first day of illness, only local changes in the lung pattern-caused by hyperemia, perivascular and peribronchial edema, and infiltration-may be seen. Therefore, chest radiographic examination is planned to be repeated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | – | Diagnostic Test: Inflammatory Biomarker EvaluationParticipants receive standard pneumonia diagnostics and treatment according to national clinical guidelines, without additional evaluation of immune response biomarkers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult hospitalized patients diagnosed with community-acquired or hospital-acquired pneumonia who meet the inclusion criteria and consent to participate in the study.
Key inclusion criteria (3 listed)
- Age ≥18 years;
- Diagnosed with community-acquired or hospital-acquired pneumonia;
- Provides written informed consent.
Key exclusion criteria (5 listed)
- Age under 18;
- Inability to provide informed consent;
- Patients with autoimmune diseases;
- Patients with chronic lung diseases such as cystic fibrosis or COPD;
- Contraindications to venipuncture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflammatory Biomarker EvaluationVenous blood samples are collected from subjects and analyzed for inflammatory biomarkers, including CD64, presepsin, IL-6, and IL-8, using a Luminex multiplex assay. Results are used for research purposes only and do not affect clinical management. | Diagnostic test | Standard Care Group |
Primary outcome
Correlation between inflammatory biomarkers and ICU admission rates
Time frame: Up to 30 days from enrollment
Measurement of serum levels of CD64 (index), presepsin (pg/ml), and IL-6 (pg/ml) using a Luminex multiplex assay in patients with community-acquired or hospital-acquired pneumonia and evaluation of their correlation with ICU admission (Incidence of cases/100000 inhabitants).
Correlation between inflammatory biomarkers and hospitalization length
Time frame: Up to 30 days from enrollment
Measurement of serum levels of CD64 (index), presepsin (pg/ml), and IL-6 (pg/ml) using a Luminex multiplex assay in patients with community-acquired or hospital-acquired pneumonia and evaluation of their correlation with hospitalization (days).
Correlation between inflammatory markers and a 30-day mortality rate
Time frame: Up to 30 days from enrollment
Measurement of serum levels of CD64 (index), presepsin (pg/ml), and IL-6 (pg/ml) using a Luminex multiplex assay in patients with community-acquired or hospital-acquired pneumonia and evaluation of their correlation with 30 day mortality rates (Incidence of cases / 100000 inhabitants)
2 secondary outcomes
Measurement of CD64 expression
Time frame: Within 30 days of enrollment
Measurement of inflammatory biomarkers
Time frame: Within 30 days of enrollment
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 8 Jun 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including all IPD collected throughout the trial, clinical and biomarker results, will be made available upon reasonable request for scientific research purposes, only IPD used in the results publication. Data will be shared under data use agreements that ensure participant confidentiality.
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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.
Astra Vitkauskiene, prof. dr., MD, PhD study director
Lithuanian University of Health Sciences
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 Community Acquired Pneumonia (CAP) and Hospital Acquired Pneumonia, run by Ruta Nutautiene at 1 site in Lithuania.
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 5 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: enrolling by invitation, as of the sponsor's last update on 8 Jun 2025. 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 Lithuania. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between inflammatory biomarkers and ICU admission rates (time frame: Up to 30 days from enrollment). The study lists 3 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 8 Jun 2025.