Innate Immune Response of Blood Cells in Patients With Pneumonia

NCT03231670 | Completed

• 1 other identifier: RT-12
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary bacterial infections such as exacerbations of chronic bronchitis, nosocomial and community-acquired pneumonia represent a major public health issue. Antibiotics have shown their efficacy by direct antimicrobial activity and their limit particularly in case of multidrug-resistant microorganisms or in treating patients with aggravating pathologies. Innate immunity could be an alternative or complementary therapeutic pathway. Innate immunity receptors bind universal and invariant microbial molecular patterns present in bacteria, virus, fungus or parasite. Toll-like Receptors (TLR) activation by microbial agonist stimulates the innate immunity response which results in the production of chemokines, cytokines, antimicrobial molecules and the recruitment of innate cells. The " Pulmonary Infection and Innate Immunity " team of the Immunity and Infection Center in Lille (Group of Dr. Sirard and Carnoy) has a long expertise in the study of TLR5 and its agonist, the flagellin, a structural protein of bacterial flagella. TLR5 is expressed on the cell surface of macrophages, monocytes, dendritic and epithelial cells. Several studies in mice have shown the flagellin prophylactic potential during bacterial infections through a TLR5 dependent stimulation of innate immunity. Recently, the group of Dr. Sirard and Carnoy has shown that flagellin can be used in association with antibiotics to treat Streptococcus pneumoniae respiratory infections in mice. The results demonstrate that an agonist of TLR can increase the therapeutic index of an antibiotic and improve the pulmonary anti-infectious reaction. This innovative approach allows us to consider new antibacterial strategies where antibiotics have reached their limit (nosocomial infection, multidrug-resistant bacteria…). TLR agonists can activate multiple human cell type. Indeed, blood cells activation by TLR agonists have been recently characterized in healthy volunteers. However, there is no available data on the ability of TLR agonists to activate cells from patients with infectious pneumopathies. A study in these patients is inevitable if one is to consider the therapeutic use of agonists in respiratory pathologies.

Conditions

Lobar Pneumonia

Outcome Measures

Primary Outcomes (1)

• Change in IL-6 specific transcripts

  IL-6 specific transcripts will be measured in blood mononuclear cells after stimulation with a TLR5 agonist.

  Baseline and 2 months

Secondary Outcomes (12)

• Change in expression of innate immunity genes after stimulation by TLR2 agonist

  Baseline and 2 months

• Change in expression of innate immunity genes after stimulation by TLR4 agonist

  Baseline and 2 months

• Change in expression of innate immunity genes after stimulation by TLR5 agonist

  Baseline and 2 months

• Change in expression of innate immunity genes after stimulation by TLR9 agonist

  Baseline and 2 months

• Change in ELISA assay on mediators of inflammation with stimulation by TRL2 agonist

  Baseline and 2 months

Study Arms (1)

lobar pneumonia

Inpatient with lobar pneumonia will undergo a blood sampling during their hospitalization and after resolution of the infection (2 Months)

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

5ml blood will be taken in addition to standard sampling

lobar pneumonia

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 patient hospitalized in the department of pneumology for whom clinical, radiological and biological criteria confirm the diagnosis of lobar pneumonia

You may qualify if:

• Adult patient hospitalized in the department of pneumology for whom clinical, radiological and biological criteria confirm the diagnosis of lobar pneumonia
• Beneficiary of the French National Health Insurance Fund
• Signed informed consent form

You may not qualify if:

• Patient under guardianship
• Patient with acute respiratory distress syndrome or septic shock
• Pregnant women
• Patient with HIV, HCV or Mycobacterium tuberculosis
• Transplanted patient receiving immunosuppressive therapy

Sponsors & Collaborators

• Lille Catholic University: lead
• Institut Pasteur de Lille: collaborator

Study Sites (1)

Hôpital Saint-Philibert

Lomme, Hauts-de-France, 59000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples 5ml

MeSH Terms

Conditions

Pneumonia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christophe Carnoy, PhD

  Institut Pasteur de Lille

  STUDY DIRECTOR

• Jean-Claude Sirard, PhD

  Institut Pasteur de Lille

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 27, 2017
• Study Start: October 20, 2017
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

FR (1)