Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Innate Immune Response of Blood Cells in Patients With Pneumonia (ASTRAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03231670
Recruitment Status : Unknown
Verified August 2018 by Lille Catholic University.
Recruitment status was:  Recruiting
First Posted : July 27, 2017
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Institut Pasteur de Lille
Information provided by (Responsible Party):
Lille Catholic University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Lobar Pneumonia Procedure: Blood sampling

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 38 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Analysis of Blood Cells Innate Immune Response in Patients With Lobar Pneumonia
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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
5ml blood will be taken in addition to standard sampling


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in IL-6 specific transcripts [ Time Frame: Baseline and 2 months ]
    IL-6 specific transcripts will be measured in blood mononuclear cells after stimulation with a TLR5 agonist.


Secondary Outcome Measures :
  1. Change in expression of innate immunity genes after stimulation by TLR2 agonist [ Time Frame: Baseline and 2 months ]
  2. Change in expression of innate immunity genes after stimulation by TLR4 agonist [ Time Frame: Baseline and 2 months ]
  3. Change in expression of innate immunity genes after stimulation by TLR5 agonist [ Time Frame: Baseline and 2 months ]
  4. Change in expression of innate immunity genes after stimulation by TLR9 agonist [ Time Frame: Baseline and 2 months ]
  5. Change in ELISA assay on mediators of inflammation with stimulation by TRL2 agonist [ Time Frame: Baseline and 2 months ]
    ELISA assay on mediators of inflammation in the supernatant of blood mononuclear cells stimulated by TRL2 agonist

  6. Change in ELISA assay on mediators of inflammation with stimulation by TRL4 agonist [ Time Frame: Baseline and 2 months ]
    ELISA assay on mediators of inflammation in the supernatant of blood mononuclear cells stimulated by TRL4 agonist

  7. Change in ELISA assay on mediators of inflammation with stimulation by TRL5 agonist [ Time Frame: Baseline and 2 months ]
    ELISA assay on mediators of inflammation in the supernatant of blood mononuclear cells stimulated by TRL5 agonist

  8. Change in ELISA assay on mediators of inflammation with stimulation by TRL9 agonist [ Time Frame: Baseline and 2 months ]
    ELISA assay on mediators of inflammation in the supernatant of blood mononuclear cells stimulated by TRL9 agonist

  9. Genotyping of TLR 2 gene [ Time Frame: Baseline ]
  10. Genotyping of TLR 4 gene [ Time Frame: Baseline ]
  11. Genotyping of TLR 5 gene [ Time Frame: Baseline ]
  12. Genotyping of TLR 9 gene [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA
Blood samples 5ml

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231670


Contacts
Layout table for location contacts
Contact: Amélie Lansiaux, MD, PhD 03 20 22 52 69 ext +33 lansiaux.amelie@ghicl.net
Contact: Jean-Jacques Vitagliano, PhD 03 20 22 57 51 vitagliano.jean-jacques@ghicl.net

Locations
Layout table for location information
France
Hôpital Saint-Philibert Recruiting
Lomme, Hauts De France, France, 59000
Contact: Anne-France Georgel         
Principal Investigator: Philippe Delecluse, MD         
Sub-Investigator: Nicolas Masson, MD         
Sponsors and Collaborators
Lille Catholic University
Institut Pasteur de Lille
Investigators
Layout table for investigator information
Study Director: Christophe Carnoy, PhD Institut Pasteur de Lille
Study Director: Jean-Claude Sirard, PhD Institut Pasteur de Lille
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03231670    
Other Study ID Numbers: RT-12
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases