Pneumonia Pathogens' Virulence Factors, Patient Inflammatory Markers, and Their Associations With Outcomes

NCT07011433 | Enrolling By Invitation DMC

• 1 other identifier: 2024-BE10-0003
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Community Acquired Pneumonia (CAP); Hospital Acquired Pneumonia

Keywords

Community-Acquired Pneumonia; Inflammatory Biomarkers; Immune response; Bronchoalveolar Lavage; Procalcitonin

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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)

  Up to 30 days from enrollment

Secondary Outcomes (2)

• Measurement of CD64 expression

  Within 30 days of enrollment

• Measurement of inflammatory biomarkers

  Within 30 days of enrollment

Study Arms (1)

Standard Care Group

Participants receive standard pneumonia diagnostics and treatment according to national clinical guidelines, without additional evaluation of immune response biomarkers.

Diagnostic Test: Inflammatory Biomarker Evaluation

Interventions

Inflammatory Biomarker Evaluation DIAGNOSTIC_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.

Standard Care Group

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

Adult hospitalized patients diagnosed with community-acquired or hospital-acquired pneumonia who meet the inclusion criteria and consent to participate in the study.

You may qualify if:

• Age ≥18 years;
• Diagnosed with community-acquired or hospital-acquired pneumonia;
• Provides written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruta Nutautiene: lead

Study Sites (1)

Department of Laboratory Medicine, Lithuanian University of Health Sciences

Kaunas, 44307, Lithuania

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be retained, however, DNA will not be extracted in the future.

MeSH Terms

Conditions

Community-Acquired Pneumonia; Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Cross Infection; Lung Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Astra Vitkauskiene, prof. dr., MD, PhD

  Lithuanian University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate, Pulmonologist

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 8, 2025
• Study Start: April 2, 2024
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: From May 2025 until the End of the Study
• Access Criteria: IPD and supporting information will be accesible only to the Investigators using special encrypted cloud database with two-factor authentication and from enlisted secure IP adresses.

Locations

LI (1)