Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03231670
Other study ID # RT-12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 20, 2017
Est. completion date June 24, 2020

Study information

Verified date March 2024
Source Lille Catholic University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date June 24, 2020
Est. primary completion date June 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Blood sampling
5ml blood will be taken in addition to standard sampling

Locations

Country Name City State
France Hôpital Saint-Philibert Lomme Hauts De France

Sponsors (2)

Lead Sponsor Collaborator
Lille Catholic University Institut Pasteur de Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in expression of innate immunity genes after stimulation by TLR2 agonist Baseline and 2 months
Secondary Change in expression of innate immunity genes after stimulation by TLR4 agonist Baseline and 2 months
Secondary Change in expression of innate immunity genes after stimulation by TLR5 agonist Baseline and 2 months
Secondary Change in expression of innate immunity genes after stimulation by TLR9 agonist Baseline and 2 months
Secondary Change in ELISA assay on mediators of inflammation with stimulation by TRL2 agonist ELISA assay on mediators of inflammation in the supernatant of blood mononuclear cells stimulated by TRL2 agonist Baseline and 2 months
Secondary Change in ELISA assay on mediators of inflammation with stimulation by TRL4 agonist ELISA assay on mediators of inflammation in the supernatant of blood mononuclear cells stimulated by TRL4 agonist Baseline and 2 months
Secondary Change in ELISA assay on mediators of inflammation with stimulation by TRL5 agonist ELISA assay on mediators of inflammation in the supernatant of blood mononuclear cells stimulated by TRL5 agonist Baseline and 2 months
Secondary Change in ELISA assay on mediators of inflammation with stimulation by TRL9 agonist ELISA assay on mediators of inflammation in the supernatant of blood mononuclear cells stimulated by TRL9 agonist Baseline and 2 months
Secondary Genotyping of TLR 2 gene Baseline
Secondary Genotyping of TLR 4 gene Baseline
Secondary Genotyping of TLR 5 gene Baseline
Secondary Genotyping of TLR 9 gene Baseline
See also
  Status Clinical Trial Phase
Completed NCT00714402 - Procalcitonin Level and Kinetics in Children With Bacterial Infections N/A