Lung DiseasesPNEUMOCHONDRIENCT03955887
Mitochondrial Dysfunction of Alveolar and Circulating Immune Cells During Acute Respiratory Distress Syndrome: Impact of Infectious Aggression and Alveolar Stretching as a Result of Mechanical Ventilation.
An observational study of Lung Diseases and Mechanical Ventilation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Sepsis leads to a deregulated host response that can lead to organ failure. During sepsis, experimental and clinical data suggest the occurrence of mitochondrial dysfunctions, particularly in circulating muscle and monocytes, which may contribute to organ failure and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Mechanical Ventilation, Bronchoalveolar Lavage
- What is being tested?
- bronchoalveolar lavage fluid (BAL) and Venous blood
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2019to 7 May 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: Patients admited in the Intensive Care Unit and the Pneumology Intensive Care Unit of the CHU Dijon Bourgogne
Who may be able to join
- Patient who has given his non-opposition (or non-opposition obtained from close relative of ventilated patients, who will be informed as soon as possible).
- Adult patient
- Group 1: patient with:
- Acute pneumonitis defined by: Signs and acute symptoms of pneumonia (new or worsening within the last 7 days), at least 2 of which are:
- Coughing
- Purulent sputum
Show all 17Show fewer
- Dyspnea
- Chest pain
- Temperature < 35°C or ≥ 38°C And a new pulmonary radiological infiltrate (x-ray or CT scan on admission)
- Not acquired under mechanical ventilation
- Complicated from ARDS according to the new Berlin definition, Chest x-ray finding bilateral parenchymal opacities not fully explained by pleural effusions, nodules or atelectasis. Respiratory distress not explained by cardiac dysfunction or overfilling. An echocardiogram will be performed in case of diagnostic uncertainty. PaO2/FiO2 report < 300 and PEP ≥ 5 cmH2O
- Requiring the use of MV.
- With a diagnostic BAL performed within 72 hours of the start of the MV
- Group 2: Patients:
- No fever during the last 15 days (reported or measured ≥ 37.8°C).
- Not under MV,
- Undergoing BAL for a reason other than acute infection (e.g. chronic interstitial syndrome, nodule or lung mass).
Who cannot join
- Patient not affiliated to the national health insurance system
- Major under judicial protection
- Pregnant, parturient or breastfeeding woman
- Known primary or secondary immune deficiency (radiotherapy, chemotherapy, immunosuppressive therapy or systemic corticosteroid therapy (>10mg/day prednisone equivalent for more than 7 days) within 6 months before inclusion, HIV infection, primary cellular immune deficiency)
- Patients with treatment known to modulate mitochondrial function, biogenesis and/or mitophagia (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, metformin, sildenafil)
- Patients with pulmonary fibrosis or cystic fibrosis known to be associated with mitochondrial alterations
Trial locations and contacts
1 site in 1 country.
About this study
Sepsis leads to a deregulated host response that can lead to organ failure. During sepsis, experimental and clinical data suggest the occurrence of mitochondrial dysfunctions, particularly in circulating muscle and monocytes, which may contribute to organ failure and death.
Lower respiratory infection is the leading cause of death from infectious causes. Mechanical ventilation (MV) is required in 20% of cases of bacterial pneumopathy with Streptococcus pneumoniae (S.p.) , with mortality reaching 50%. There are then frequently criteria for acute respiratory distress syndrome (ARDS), combining bilateral lung involvement and marked hypoxemia.
Read more
Cyclic stretching of lung cells induced by MV causes sterile inflammation and tissue damage (i.e. ventilator-induced lung injury [VILI]), which can cause cellular dysfunction that alter the immune response, particularly during ARDS. This is why the application of a so-called protective MV is then required. However, this does not prevent about one-third of patients from showing signs of alveolar overdistension, as evidenced by an increase in motor pressure (MP) (MP≥ 15 cmH2O), associated with an increase in mortality.
The deleterious effects of MV could be explained by the occurrence of mitochondrial abnormalities. Indeed, the cyclic stretching of lung cells leads to dysfunction in the respiratory chain and the production of free oxygen radicals (FOS), altering membrane permeability. These phenomena could promote VILI, facilitate the translocation of bacteria from the lung to the systemic compartment and lead to alterations in immune response.
In our model of S.p. pneumopathy in rabbits, animals on MV develop more severe lung disorders (lack of pulmonary clearance of bacteria, bacterial translocation in the blood, excess mortality), compared to animals on spontaneous ventilation (SV). Intracellular pulmonary mitochondrial DNA (mtDNA) concentrations, a reflection of the mitochondrial pool, are significantly decreased in ventilated rabbits compared to SV rabbits and in infected rabbits compared to uninfected rabbits. At the same time, the mitochondrial content of circulating cells decreased early (H8) in all infected rabbits, but was only restored in rabbits in SV, those who survived pneumonia (Blot et al, poster ECCMID 2015, submitted article). These data suggest an alteration in the mechanisms that restore mitochondrial homeostasis (mitochondrial biogenesis and mitophagy) during the dual infection/MV agression, which may explain the observed excess mortality. Other work by our team illustrates the importance of these phenomena by showing in a mouse model of polymicrobial infection that inhibition of mitophagia in macrophages promotes survival (Patoli et al, in preparation). Human data on this subject are non-existent.
The phenomena of mitochondrial dysfunction nevertheless deserve to be explored in humans during the combined MV/pneumopathy aggression in order to understand its possible impact on the effectiveness of the host's immune response. In a personalized medicine approach, these data would open up prospects for targeted therapies, capable of activating mitochondrial biogenesis and/or modulating mitophagia, to prevent organ dysfunction and mortality during severe CALs treated with antibiotic therapy.
- Being tested
- bronchoalveolar lavage fluid (BAL), Venous blood
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoalveolar lavage fluid (BAL)Biological
Recovery of a 10 mL volume of BAL fluid, performed as part of patient care
Venous bloodBiological
Collection of 3 additional blood tubes (12 ml) during a blood sample taken as part of patient care
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients with severe acute lung disease requiring mechanical ventilation Receives: Biological: bronchoalveolar lavage fluid (BAL); Biological: Venous blood | |
| Control | Patients receiving routine bronchoalveolar lavage for a pathology not suspected of acute infection Receives: Biological: bronchoalveolar lavage fluid (BAL); Biological: Venous blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active mitochondria content of alveolar macrophages
Measured: Through study completion, an average of 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start11 Jun 2019
- Primary completion7 May 2020
- Study completion7 May 2020
Why it stopped: technical difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955887
- Sponsor's protocol ID
- BLOT MSD-APJ 2018
- Acronym
- PNEUMOCHONDRIE
- Status last verified
- Jan 2026
- First submitted
- 16 May 2019
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blot M, Bour JB, Quenot JP, Bourredjem A, Nguyen M, Guy J, Monier S, Georges M, Large A, Dargent A, Guilhem A, Mouries-Martin S, Barben J, Bouhemad B, Charles PE, Chavanet P, Binquet C, Piroth L; LYMPHONIE study group. The dysregulated innate immune response in severe COVID-19 pneumonia that could drive poorer outcome. J Transl Med. 2020 Dec 3;18(1):457. doi: 10.1186/s12967-020-02646-9.
PubMed 33272291Blot M, Jacquier M, Aho Glele LS, Beltramo G, Nguyen M, Bonniaud P, Prin S, Andreu P, Bouhemad B, Bour JB, Binquet C, Piroth L, Pais de Barros JP, Masson D, Quenot JP, Charles PE; Pneumochondrie study group. CXCL10 could drive longer duration of mechanical ventilation during COVID-19 ARDS. Crit Care. 2020 Nov 2;24(1):632. doi: 10.1186/s13054-020-03328-0.
PubMed 33138839
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Dysfunction of Alveolar and Circulating Immune Cells During Acute Respiratory Distress Syndrome: Impact of Infectious Aggression and Alveolar Stretching as a Result of Mechanical Ventilation.
- ClinicalTrials.gov ID
- NCT03955887
- Acronym / sponsor ID
- PNEUMOCHONDRIE / BLOT MSD-APJ 2018
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: technical difficulties
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 20 May 2019 (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.
Sepsis leads to a deregulated host response that can lead to organ failure. During sepsis, experimental and clinical data suggest the occurrence of mitochondrial dysfunctions, particularly in circulating muscle and monocytes, which may contribute to organ failure and death.
Lower respiratory infection is the leading cause of death from infectious causes. Mechanical ventilation (MV) is required in 20% of cases of bacterial pneumopathy with Streptococcus pneumoniae (S.p.) , with mortality reaching 50%. There are then frequently criteria for acute respiratory distress syndrome (ARDS), combining bilateral lung involvement and marked hypoxemia.
Cyclic stretching of lung cells induced by MV causes sterile inflammation and tissue damage (i.e. ventilator-induced lung injury [VILI]), which can cause cellular dysfunction that alter the immune response, particularly during ARDS. This is why the application of a so-called protective MV is then required. However, this does not prevent about one-third of patients from showing signs of alveolar overdistension, as evidenced by an increase in motor pressure (MP) (MP≥ 15 cmH2O), associated with an increase in mortality.
The deleterious effects of MV could be explained by the occurrence of mitochondrial abnormalities. Indeed, the cyclic stretching of lung cells leads to dysfunction in the respiratory chain and the production of free oxygen radicals (FOS), altering membrane permeability. These phenomena could promote VILI, facilitate the translocation of bacteria from the lung to the systemic compartment and lead to alterations in immune response.
In our model of S.p. pneumopathy in rabbits, animals on MV develop more severe lung disorders (lack of pulmonary clearance of bacteria, bacterial translocation in the blood, excess mortality), compared to animals on spontaneous ventilation (SV). Intracellular pulmonary mitochondrial DNA (mtDNA) concentrations, a reflection of the mitochondrial pool, are significantly decreased in ventilated rabbits compared to SV rabbits and in infected rabbits compared to uninfected rabbits. At the same time, the mitochondrial content of circulating cells decreased early (H8) in all infected rabbits, but was only restored in rabbits in SV, those who survived pneumonia (Blot et al, poster ECCMID 2015, submitted article). These data suggest an alteration in the mechanisms that restore mitochondrial homeostasis (mitochondrial biogenesis and mitophagy) during the dual infection/MV agression, which may explain the observed excess mortality. Other work by our team illustrates the importance of these phenomena by showing in a mouse model of polymicrobial infection that inhibition of mitophagia in macrophages promotes survival (Patoli et al, in preparation). Human data on this subject are non-existent.
The phenomena of mitochondrial dysfunction nevertheless deserve to be explored in humans during the combined MV/pneumopathy aggression in order to understand its possible impact on the effectiveness of the host's immune response. In a personalized medicine approach, these data would open up prospects for targeted therapies, capable of activating mitochondrial biogenesis and/or modulating mitophagia, to prevent organ dysfunction and mortality during severe CALs treated with antibiotic therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Biological: bronchoalveolar lavage fluid (BAL), Biological: Venous bloodPatients with severe acute lung disease requiring mechanical ventilation |
| Control | – | Biological: bronchoalveolar lavage fluid (BAL), Biological: Venous bloodPatients receiving routine bronchoalveolar lavage for a pathology not suspected of acute infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admited in the Intensive Care Unit and the Pneumology Intensive Care Unit of the CHU Dijon Bourgogne
Key inclusion criteria (17 listed)
- Patient who has given his non-opposition (or non-opposition obtained from close relative of ventilated patients, who will be informed as soon as possible).
- Adult patient
- Group 1: patient with:
- Group 2: Patients:
Key exclusion criteria (6 listed)
- Patient not affiliated to the national health insurance system
- Major under judicial protection
- Pregnant, parturient or breastfeeding woman
- Known primary or secondary immune deficiency (radiotherapy, chemotherapy, immunosuppressive therapy or systemic corticosteroid therapy (>10mg/day prednisone equivalent for more than 7 days) within 6 months before inclusion, HIV infection, primary cellular immune deficiency)
- Patients with treatment known to modulate mitochondrial function, biogenesis and/or mitophagia (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, metformin, sildenafil)
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 |
|---|---|---|
| bronchoalveolar lavage fluid (BAL)Recovery of a 10 mL volume of BAL fluid, performed as part of patient care | Biological | Control, Experimental |
| Venous bloodCollection of 3 additional blood tubes (12 ml) during a blood sample taken as part of patient care | Biological | Control, Experimental |
Primary outcome
Active mitochondria content of alveolar macrophages
Time frame: Through study completion, an average of 19 months
Results and safety
The study was stopped early (reason given: technical difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 33272291Blot M, Bour JB, Quenot JP, Bourredjem A, Nguyen M, Guy J, Monier S, Georges M, Large A, Dargent A, Guilhem A, Mouries-Martin S, Barben J, Bouhemad B, Charles PE, Chavanet P, Binquet C, Piroth L; LYMPHONIE study group. The dysregulated innate immune response in severe COVID-19 pneumonia that could drive poorer outcome. J Transl Med. 2020 Dec 3;18(1):457. doi: 10.1186/s12967-020-02646-9.
- Derived from this study: PubMed 33138839Blot M, Jacquier M, Aho Glele LS, Beltramo G, Nguyen M, Bonniaud P, Prin S, Andreu P, Bouhemad B, Bour JB, Binquet C, Piroth L, Pais de Barros JP, Masson D, Quenot JP, Charles PE; Pneumochondrie study group. CXCL10 could drive longer duration of mechanical ventilation during COVID-19 ARDS. Crit Care. 2020 Nov 2;24(1):632. doi: 10.1186/s13054-020-03328-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Diseases and Mechanical Ventilation, run by Centre Hospitalier Universitaire Dijon 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 17 inclusion and 6 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 3 Feb 2026. 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 was stopped early (reason given: technical difficulties). 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?
Active mitochondria content of alveolar macrophages (time frame: Through study completion, an average of 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03955887, which also lists 2 linked publications.
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 3 Feb 2026.