Community-acquired PneumoniaImPACTNCT03379207
Innate Immune Response During Community Acquired Pneumonia
An observational study of Community-acquired Pneumonia and Acute Respiratory Distress Syndrome, run by University Hospital, Tours at 3 sites in France.
Trial summary
Community acquired pneumonia (CAP) is a major cause of morbidity and mortality worldwide. Despite recent improvement in acute management (specifically for administration of antibiotics) many severe presentations of pneumonia worsen, progressing to Acute Respiratory Distress Syndrome (ARDS), a clinical entity with 40%… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Acute Respiratory Distress Syndrome, Innate Immunity
- What is being tested?
- Blood samples, Tracheal Aspirates and Surplus of Broncho-alveolar lavage fluid
- How many people
- 258 participants
- Where
- 3 sitesFrance
- Study dates
- 10 Jan 2018to 4 Jun 2025
- 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: Participants admitted to the Intensive Care Unit of the University Hospital of Tours or University Hospital of Limoges (France) with an initial diagnosis of Community Acquired Pneumonia, or participants admitted without diagnosis of pneumonia or shock and for whom invasive mechanical ventilation is required.
Who may be able to join
- "Pneumonia" group:
- Admission to the Intensive Care Units or Pneumonia service of Tours University Hospital or Intensive Care Unit or Limoges University Hospital
- Initial diagnosis of acute community-acquired pneumonia suggested by the presence of a cough, dirty sputum, chest pain and / or dyspnea (at least two criteria required), associated with the presence of a radiological or CT infiltrate initially
- Patient for whom it is not envisaged, a priori, to limit treatment within 5 days following inclusion, for ethical reasons, due to age and advanced comorbidities, and / or a level of severity beyond all therapeutic possibilities.
- Diagnosis of pneumonia done within 48 hours after admission to the hospital
- Participant admitted to the hospital for less than 8 days
Show all 14Show fewer
- "Control" group:
- Admission to the Intensive Care Units of the University Hospital of Tours or Limoges University Hospital
- Use of invasive mechanical ventilation for less than 48 hours
- Predictable duration of invasive mechanical ventilation> 48h
- Participant admitted to the hospital for less than 8 days
- Absence of pneumonia criteria (according to the criteria defined for the "Pneumonia" participant group)
- Absence shock (defined by the need for vasopressor despite volume expansion ≥30mL/kg, associated with a blood lactate level ≥ 2mmol / L
- Patient for whom it is not envisaged, a priori, to limit treatment within 5 days following inclusion, for ethical reasons, due to age and advanced comorbidities, and / or a level of severity beyond all therapeutic possibilities.
Who cannot join
- Participant under protection
- Pregnant or lactating women
Trial locations and contacts
3 sites in 1 country.
France3 sites
University Hospitakl of TOURS Département of Pneumonia
Tours, 37044
University Hospital -Bretonneau - Intensive Care
Tours, 37044
University Hospital of Tours; INSERM CIC 1415
Tours, 37044
About this study
Official title: Innate Immunity During Community Acquired Pneumonia: A Translational Approach
Community acquired pneumonia (CAP) is a major cause of morbidity and mortality worldwide. Despite recent improvement in acute management (specifically for administration of antibiotics) many severe presentations of pneumonia worsen, progressing to Acute Respiratory Distress Syndrome (ARDS), a clinical entity with 40% hospital mortality.
Dysregulation of immune response is thought to be largely implicated in severe pneumonia progressing to ARDS. Notably, experimental studies have recently suggested the implication of non-conventional T lymphocytes and innate cells in this immunopathology. However, no data are available in Humans in clinical settings.
Read more
This study aims to explore the role of non-conventional T cells in pneumonia and ARDS, in participants. For this purpose, 100 participants admitted to Intensive Care Unit (ICU) with a diagnosis of CAP will be included, and 50 "control" participants with no pneumonia nor shock. Presence and functionality of non-conventional T cells and innate cells will be explored using flow-cytometry and ex-vivo stimulation, alongside with cytokines productions. These analyses are conducted in the blood, and, for invasively ventilated participants, in tracheal aspirates or broncho-alveolar fluids if available. For each participants included, the analyses are conducted at different time-points during ICU stay: inclusion, day 3, day 8 and day 15. Moreover, participants with ARDS, for whom a post-ICU follow-up program is normally established after discharge, will have blood analysis from blood samples taken during the follow-up visit up to 8 months after inclusion.
Immunophenotypage and functionality of non-conventional T cells and innate cells will be compared to clinical parameters and their evolution, between "CAP" participants and "Control" participants", and for each participants, according to the different time-point of analysis, in order to better understand dynamic of innate immunity during pneumonia and ARDS.
Read the detailed description
- Clinical and scientific background:
Community acquired pneumonia is a major cause of morbidity and mortality worldwide. Despite recent improvement in acute management (specifically for administration of antibiotics), severe pneumonia can worsen and ultimately progressing to Acute Respiratory Distress Syndrome (ARDS), a clinical entity with an inacceptable 40% hospital mortality. From a pathophysiological point of view, ARDS is characterized by a deregulation of pulmonary inflammation initially triggered by the local aggression, which is, in two-third of the cases, a pneumonia. Alteration of tissue repair is another major characteristic of this entity. So far, the scientific knowledge on this pathophysiology did not translate into specific therapy that could modulate efficiently the inflammatory response and to control the progression from pneumonia to ARDS, and/or to improve tissue repair. Thus, a complete reconsideration of the pathophysiological mechanisms is mandatory. Recent progresses in mucosal biology and innate immunity give interesting new opportunities. Specifically, recently discovered unconventional T cells have shown to be major actors in shaping and modulating early immune responses in the lung mucosa during microbial aggressions and for secondary tissue repair. However, these evidences are limited to pre-clinical models. In many other human diseases (oncology, immune diseases), these sub-populations are already being explored as potential targets for immune therapies.
- Objective of the study:
The aim of this study is to explore potential implications of unconventional T cells during human severe pneumonia and ARDS.
This translational study will complement experimental approaches currently undertaken in the laboratory exploring the role of unconventional T cells in murine models of severe pneumonia and ARDS.
- Design:
This is a prospective single-center study including participants admitted in Intensive Care Department of the university hospital of Tours for community-acquired pneumonia. Given the exploratory nature of the study, we designed a "control" group of participants admitted to ICU without evident signs of pneumonia and shock.
Number of participants: 300 for "pneumonia" group, and 50 for "control" group
- Interventions and analysis:
Blood samples will be collected at inclusion, day 3, 8 and 15 during patient's stay in ICU. For mechanically ventilated participants, tracheal aspirates will be also collected at the same timing. If available, broncho-alveolar lavages will be also collected. If ARDS or Ventilator Associated Pneumonia (VAP) are subsequently diagnosed, supplemental blood and tracheal aspirates samples will be collected.
Blood samples and airway fluid samples will be treated to perform flow cytometry analysis for immunophenotypage (cellular content). In some cases, intra-cellular staining will be performed to assess cytokine production and/or transcription factor expression. Functions of unconventional T cells will also be performed after ex vivo stimulation on purified population (cell sorting). Cytokine level sand transcriptomic analyses will also be performed on blood samples.
Clinical characteristics (including respiratory parameters, blood gas, organ dysfunctions, survival at day 28 and day 90) will also be collected. Thus, frequency, activation status and functions of unconventional T cells will be dynamically analyzed in regard of clinical evolution within-individuals and across pneumonia vs control groups. A particular focus will be made on respiratory parameters (ventilation mode, and for participants with ARDS, P/F ratio, driving pressure), organ dysfunctions (as measured by SOFA score), and microbial documentation of the pneumonia.
Moreover, participants treated for ARDS are usually followed in a post-ICU follow-up clinic program in the ICU where the research is conducted. Thus, investigators will perform analysis of the unconventional T cell compartment (blood samples) in the participants firstly enrolled in the study. This will allow exploration of long-term imprinting on the innate immune response after the initial trigger.
- Being tested
- Blood samples, Tracheal Aspirates, Surplus of Broncho-alveolar lavage fluid
- Keywords
- Community-acquired Pneumonia, Acute Respiratory Distress Syndrome, Innate Immunity, Non Conventional T Lymphocytes
- Medical subject headings
- Community-Acquired Pneumonia, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Blood samples for research purpose, taken whenever possible during blood sampling for routine purpose
Tracheal AspiratesOther
Only for mechanically ventilated participants.
Surplus of Broncho-alveolar lavage fluidOther
Only if performed for diagnosis purpose by the treating investigator : indication left at his discretion
| Study group | Role | What they receive |
|---|---|---|
| "Community Acquired Pneumonia" group | Participants admitted to Intensive Care Unit (ICU) of University Hospital of Tours (France) for Community Acquired Pneumonia.
Interventions:
* Blood samples for research purpose, taken whenever possible during blood sampling for routine purpose, at inclusion, day 1, 7, and every week during ICU stay Tracheal Aspirates for research purpose: only for mechanically ventilated participants, at inclusion, day 1, 7, and and every week during ICU stay
* Surplus of Broncho-alveolar lavage fluid: only if performed for diagnosis purpose by the treating investigator (indication left at his discretion) Receives: Other: Blood samples; Other: Tracheal Aspirates; Other: Surplus of Broncho-alveolar lavage fluid | |
| "Control" group | Participants admitted to Intensive Care Unit of University Hospital of Tours (France) for whom invasive mechanical ventilation is required for an estimated duration of at least 48h, without diagnosis of pneumonia or shock.
Interventions:
* Blood samples for research purpose, taken whenever possible during blood sampling for routine purpose, at inclusion, day 3, 8, and 15 during ICU stay Tracheal Aspirates for research purpose: at inclusion, day 3, 8, and 15 during invasive mechanical ventilation period,
* Surplus of Broncho-alveolar lavage fluid: only if performed for diagnosis purpose by the treating investigator (indication left at his discretion) Receives: Other: Blood samples; Other: Tracheal Aspirates; Other: Surplus of Broncho-alveolar lavage fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood level of Non-Conventional T Lymphocytes (expressed as % CD3+ lymphocytes)
Measured: 8 Months
Airway level of Non-Conventional T Lymphocytes (expressed as % CD3+ lymphocytes)
Measured: 8 Months
Blood level of inflammatory cytokines
Measured: 8 months
Airway level of inflammatory cytokines
Measured: 8 months
Secondary outcomes (6)
Blood level of Conventional T Lymphocytes (expressed as % CD3+ lymphocytes)
Measured: 8 months
Airway level of Conventional T Lymphocytes (expressed as % CD3+ lymphocytes)
Measured: 8 months
Metabolic signature of non-conventional T lymphocytes
Measured: 8 months
Transcriptomic signature of non-conventional T lymphocytes
Measured: 8 Months
Blood level of Innate Cells (expressed as % CD45+ lymphocytes)
Measured: 8 months
AIrway level of Innate Cells (expressed as % CD45+ lymphocytes)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start10 Jan 2018
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Why it stopped: A new project has been started. It extends ImPACT, with more financial resources and with scientific questions that have evolved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youenn JOUAN, MD-PHD, Study director, University of TOURS-INSERM U1100
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379207
- Sponsor's protocol ID
- PHAO17/YJ-ImPACT
- Acronym
- ImPACT
- Status last verified
- Nov 2025
- First submitted
- 15 Dec 2017
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate Immunity During Community Acquired Pneumonia: A Translational Approach
- ClinicalTrials.gov ID
- NCT03379207
- Acronym / sponsor ID
- ImPACT / PHAO17/YJ-ImPACT
- Keywords
- Community-acquired Pneumonia, Acute Respiratory Distress Syndrome, Innate Immunity, Non Conventional T Lymphocytes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: A new project has been started. It extends ImPACT, with more financial resources and with scientific questions that have evolved.
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 20 Dec 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.
Community acquired pneumonia (CAP) is a major cause of morbidity and mortality worldwide. Despite recent improvement in acute management (specifically for administration of antibiotics) many severe presentations of pneumonia worsen, progressing to Acute Respiratory Distress Syndrome (ARDS), a clinical entity with 40% hospital mortality.
Dysregulation of immune response is thought to be largely implicated in severe pneumonia progressing to ARDS. Notably, experimental studies have recently suggested the implication of non-conventional T lymphocytes and innate cells in this immunopathology. However, no data are available in Humans in clinical settings.
This study aims to explore the role of non-conventional T cells in pneumonia and ARDS, in participants. For this purpose, 100 participants admitted to Intensive Care Unit (ICU) with a diagnosis of CAP will be included, and 50 "control" participants with no pneumonia nor shock. Presence and functionality of non-conventional T cells and innate cells will be explored using flow-cytometry and ex-vivo stimulation, alongside with cytokines productions. These analyses are conducted in the blood, and, for invasively ventilated participants, in tracheal aspirates or broncho-alveolar fluids if available. For each participants included, the analyses are conducted at different time-points during ICU stay: inclusion, day 3, day 8 and day 15. Moreover, participants with ARDS, for whom a post-ICU follow-up program is normally established after discharge, will have blood analysis from blood samples taken during the follow-up visit up to 8 months after inclusion.
Immunophenotypage and functionality of non-conventional T cells and innate cells will be compared to clinical parameters and their evolution, between "CAP" participants and "Control" participants", and for each participants, according to the different time-point of analysis, in order to better understand dynamic of innate immunity during pneumonia and ARDS.
Detailed description
- Clinical and scientific background:
Community acquired pneumonia is a major cause of morbidity and mortality worldwide. Despite recent improvement in acute management (specifically for administration of antibiotics), severe pneumonia can worsen and ultimately progressing to Acute Respiratory Distress Syndrome (ARDS), a clinical entity with an inacceptable 40% hospital mortality. From a pathophysiological point of view, ARDS is characterized by a deregulation of pulmonary inflammation initially triggered by the local aggression, which is, in two-third of the cases, a pneumonia. Alteration of tissue repair is another major characteristic of this entity. So far, the scientific knowledge on this pathophysiology did not translate into specific therapy that could modulate efficiently the inflammatory response and to control the progression from pneumonia to ARDS, and/or to improve tissue repair. Thus, a complete reconsideration of the pathophysiological mechanisms is mandatory. Recent progresses in mucosal biology and innate immunity give interesting new opportunities. Specifically, recently discovered unconventional T cells have shown to be major actors in shaping and modulating early immune responses in the lung mucosa during microbial aggressions and for secondary tissue repair. However, these evidences are limited to pre-clinical models. In many other human diseases (oncology, immune diseases), these sub-populations are already being explored as potential targets for immune therapies.
- Objective of the study:
The aim of this study is to explore potential implications of unconventional T cells during human severe pneumonia and ARDS.
This translational study will complement experimental approaches currently undertaken in the laboratory exploring the role of unconventional T cells in murine models of severe pneumonia and ARDS.
- Design:
This is a prospective single-center study including participants admitted in Intensive Care Department of the university hospital of Tours for community-acquired pneumonia. Given the exploratory nature of the study, we designed a "control" group of participants admitted to ICU without evident signs of pneumonia and shock.
Number of participants: 300 for "pneumonia" group, and 50 for "control" group
- Interventions and analysis:
Blood samples will be collected at inclusion, day 3, 8 and 15 during patient's stay in ICU. For mechanically ventilated participants, tracheal aspirates will be also collected at the same timing. If available, broncho-alveolar lavages will be also collected. If ARDS or Ventilator Associated Pneumonia (VAP) are subsequently diagnosed, supplemental blood and tracheal aspirates samples will be collected.
Blood samples and airway fluid samples will be treated to perform flow cytometry analysis for immunophenotypage (cellular content). In some cases, intra-cellular staining will be performed to assess cytokine production and/or transcription factor expression. Functions of unconventional T cells will also be performed after ex vivo stimulation on purified population (cell sorting). Cytokine level sand transcriptomic analyses will also be performed on blood samples.
Clinical characteristics (including respiratory parameters, blood gas, organ dysfunctions, survival at day 28 and day 90) will also be collected. Thus, frequency, activation status and functions of unconventional T cells will be dynamically analyzed in regard of clinical evolution within-individuals and across pneumonia vs control groups. A particular focus will be made on respiratory parameters (ventilation mode, and for participants with ARDS, P/F ratio, driving pressure), organ dysfunctions (as measured by SOFA score), and microbial documentation of the pneumonia.
Moreover, participants treated for ARDS are usually followed in a post-ICU follow-up clinic program in the ICU where the research is conducted. Thus, investigators will perform analysis of the unconventional T cell compartment (blood samples) in the participants firstly enrolled in the study. This will allow exploration of long-term imprinting on the innate immune response after the initial trigger.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Community Acquired Pneumonia" group | – | Other: Blood samples, Other: Tracheal Aspirates, Other: Surplus of Broncho-alveolar lavage fluidParticipants admitted to Intensive Care Unit (ICU) of University Hospital of Tours (France) for Community Acquired Pneumonia. Interventions: * Blood samples for research purpose, taken whenever possible during blood sampling for routine purpose, at inclusion, day 1, 7, and every week during ICU stay Tracheal Aspirates for research purpose: only for mechanically ventilated participants, at inclusion, day 1, 7, and and every week during ICU stay * Surplus of Broncho-alveolar lavage fluid: only if performed for diagnosis purpose by the treating investigator (indication left at his discretion) |
| "Control" group | – | Other: Blood samples, Other: Tracheal Aspirates, Other: Surplus of Broncho-alveolar lavage fluidParticipants admitted to Intensive Care Unit of University Hospital of Tours (France) for whom invasive mechanical ventilation is required for an estimated duration of at least 48h, without diagnosis of pneumonia or shock. Interventions: * Blood samples for research purpose, taken whenever possible during blood sampling for routine purpose, at inclusion, day 3, 8, and 15 during ICU stay Tracheal Aspirates for research purpose: at inclusion, day 3, 8, and 15 during invasive mechanical ventilation period, * Surplus of Broncho-alveolar lavage fluid: only if performed for diagnosis purpose by the treating investigator (indication left at his discretion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants admitted to the Intensive Care Unit of the University Hospital of Tours or University Hospital of Limoges (France) with an initial diagnosis of Community Acquired Pneumonia, or participants admitted without diagnosis of pneumonia or shock and for whom invasive mechanical ventilation is required.
Key inclusion criteria (14 listed)
- Admission to the Intensive Care Units or Pneumonia service of Tours University Hospital or Intensive Care Unit or Limoges University Hospital
- Initial diagnosis of acute community-acquired pneumonia suggested by the presence of a cough, dirty sputum, chest pain and / or dyspnea (at least two criteria required), associated with the presence of a radiological or CT infiltrate initially
- Patient for whom it is not envisaged, a priori, to limit treatment within 5 days following inclusion, for ethical reasons, due to age and advanced comorbidities, and / or a level of severity beyond all therapeutic possibilities.
- Diagnosis of pneumonia done within 48 hours after admission to the hospital
- Participant admitted to the hospital for less than 8 days
Key exclusion criteria (2 listed)
- Participant under protection
- Pregnant or lactating women
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 samplesBlood samples for research purpose, taken whenever possible during blood sampling for routine purpose | Other | "Community Acquired Pneumonia" group, "Control" group |
| Tracheal AspiratesOnly for mechanically ventilated participants. | Other | "Community Acquired Pneumonia" group, "Control" group |
| Surplus of Broncho-alveolar lavage fluidOnly if performed for diagnosis purpose by the treating investigator : indication left at his discretion | Other | "Community Acquired Pneumonia" group, "Control" group |
Primary outcome
Blood level of Non-Conventional T Lymphocytes (expressed as % CD3+ lymphocytes)
Time frame: 8 Months
Airway level of Non-Conventional T Lymphocytes (expressed as % CD3+ lymphocytes)
Time frame: 8 Months
Blood level of inflammatory cytokines
Time frame: 8 months
Airway level of inflammatory cytokines
Time frame: 8 months
6 secondary outcomes
Blood level of Conventional T Lymphocytes (expressed as % CD3+ lymphocytes)
Time frame: 8 months
Airway level of Conventional T Lymphocytes (expressed as % CD3+ lymphocytes)
Time frame: 8 months
Metabolic signature of non-conventional T lymphocytes
Time frame: 8 months
Transcriptomic signature of non-conventional T lymphocytes
Time frame: 8 Months
Blood level of Innate Cells (expressed as % CD45+ lymphocytes)
Time frame: 8 months
AIrway level of Innate Cells (expressed as % CD45+ lymphocytes)
Time frame: 8 months
Results and safety
The study was stopped early (reason given: A new project has been started. It extends ImPACT, with more financial resources and with scientific questions that have evolved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Community-acquired Pneumonia
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingPhase 3
CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL
Sepsis
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
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.
Youenn JOUAN, MD-PHD study director
University of TOURS-INSERM U1100
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia and Acute Respiratory Distress Syndrome, run by University Hospital, Tours at 3 sites 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 14 inclusion and 2 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: stopped early, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: A new project has been started. It extends ImPACT, with more financial resources and with scientific questions that have evolved.). Results are not available in the source record.
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?
Blood level of Non-Conventional T Lymphocytes (expressed as % CD3+ lymphocytes) (time frame: 8 Months). The study lists 4 primary outcomes in all. 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 24 Nov 2025.