Lobar PneumoniaASTRALNCT03231670
Innate Immune Response of Blood Cells in Patients With Pneumonia
An observational study of Lobar Pneumonia, run by Lille Catholic University at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lobar Pneumonia
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2017to 24 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 patient hospitalized in the department of pneumology for whom clinical, radiological and biological criteria confirm the diagnosis of lobar pneumonia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Blood Cells Innate Immune Response in Patients With Lobar Pneumonia
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
- Being tested
- Blood sampling
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
5ml blood will be taken in addition to standard sampling
| Study group | Role | What they receive |
|---|---|---|
| lobar pneumonia | Inpatient with lobar pneumonia will undergo a blood sampling during their hospitalization and after resolution of the infection (2 Months) Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IL-6 specific transcripts
IL-6 specific transcripts will be measured in blood mononuclear cells after stimulation with a TLR5 agonist.
Measured: Baseline and 2 months
Secondary outcomes (12)
Change in expression of innate immunity genes after stimulation by TLR2 agonist
Measured: Baseline and 2 months
Change in expression of innate immunity genes after stimulation by TLR4 agonist
Measured: Baseline and 2 months
Change in expression of innate immunity genes after stimulation by TLR5 agonist
Measured: Baseline and 2 months
Change in expression of innate immunity genes after stimulation by TLR9 agonist
Measured: Baseline and 2 months
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
Measured: Baseline and 2 months
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
Measured: Baseline and 2 months
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
Measured: Baseline and 2 months
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
Measured: Baseline and 2 months
Genotyping of TLR 2 gene
Measured: Baseline
Genotyping of TLR 4 gene
Measured: Baseline
Genotyping of TLR 5 gene
Measured: Baseline
Genotyping of TLR 9 gene
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start20 Oct 2017
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lobar PneumoniaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur de Lille
- Responsible party
- Sponsor
- Investigators
- Christophe Carnoy, PhD, Study director, Institut Pasteur de LilleJean-Claude Sirard, PhD, Study director, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231670
- Sponsor's protocol ID
- RT-12
- Acronym
- ASTRAL
- Status last verified
- Mar 2024
- First submitted
- 24 Jul 2017
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Blood Cells Innate Immune Response in Patients With Lobar Pneumonia
- ClinicalTrials.gov ID
- NCT03231670
- Acronym / sponsor ID
- ASTRAL / RT-12
- Conditions
- Lobar Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Institut Pasteur de Lille
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 27 Jul 2017 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lobar pneumonia | – | Procedure: Blood samplingInpatient with lobar pneumonia will undergo a blood sampling during their hospitalization and after resolution of the infection (2 Months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient hospitalized in the department of pneumology for whom clinical, radiological and biological criteria confirm the diagnosis of lobar pneumonia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Blood sampling5ml blood will be taken in addition to standard sampling | Procedure or surgery | lobar pneumonia |
Primary outcome
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.
12 secondary outcomes
Change in expression of innate immunity genes after stimulation by TLR2 agonist
Time frame: Baseline and 2 months
Change in expression of innate immunity genes after stimulation by TLR4 agonist
Time frame: Baseline and 2 months
Change in expression of innate immunity genes after stimulation by TLR5 agonist
Time frame: Baseline and 2 months
Change in expression of innate immunity genes after stimulation by TLR9 agonist
Time frame: Baseline and 2 months
Change in ELISA assay on mediators of inflammation with stimulation by TRL2 agonist
Time frame: Baseline and 2 months
Change in ELISA assay on mediators of inflammation with stimulation by TRL4 agonist
Time frame: Baseline and 2 months
Change in ELISA assay on mediators of inflammation with stimulation by TRL5 agonist
Time frame: Baseline and 2 months
Change in ELISA assay on mediators of inflammation with stimulation by TRL9 agonist
Time frame: Baseline and 2 months
Genotyping of TLR 2 gene
Time frame: Baseline
Genotyping of TLR 4 gene
Time frame: Baseline
Genotyping of TLR 5 gene
Time frame: Baseline
Genotyping of TLR 9 gene
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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. This study is not recruiting at the moment.
Christophe Carnoy, PhD study director
Institut Pasteur de Lille
Jean-Claude Sirard, PhD study director
Institut Pasteur de Lille
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 Lobar Pneumonia, run by Lille Catholic University at 1 site in France.
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: finished, as of the sponsor's last update on 6 Mar 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in IL-6 specific transcripts (time frame: Baseline and 2 months). 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 6 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.