PneumoniaLYMPHONIENCT03505281
Evaluation of a Functional Lymphocyte Test (QuantiFERON Monitor®) as a Prognostic Marker for Acute Community-acquired Pneumonia
An observational study of Pneumonia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Lower respiratory infections, or pneumonia, remain the third leading cause of death worldwide, despite progress in vaccinating at-risk populations and improved resuscitation techniques. Research shows that immune defences are weakened during severe infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Blood samples
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2018to 30 Jul 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: Acute community-acquired pneumonia
Who may be able to join
- GROUP OF PATIENTS WITH PNEUMONIA
- Patient with acute pneumonitis:
- 1) Acute signs and symptoms of lung disease (new or worsening), including at least 2 of the following:
- Cough
- Dyspnea
- Purulent sputum
Show all 28Show fewer
- Chest pain
- Temperature ≥ 38°C or < 35°C 2) and new radiological pulmonary infiltrate (X-ray or CT scan on admission)
- Community Acquired Pneumonia:
- Pneumonia present on admission or diagnosed within 48 hours of admission,
- Poor prognosis according to the new quick SOFA sepsis score; poor prognosis is defined if at least 2 of the following criteria are present:
- Systolic blood pressure ≤ 100 mm Hg,
- Respiratory rate ≥ 22,
- Altered consciousness (Glasgow score < 15). And/or need for mechanical ventilation (invasive or non-invasive). And/or need for use of vasopressors for hemodynamic failure.
- Patient of legal age who has given informed consent
- Patient affiliated to the national health insurance system
- For patients with "severe SARS-CoV-2 pneumonia":
- Respiratory specimen positive for SARS-CoV-2 (PCR)
- And without Gram-negative bacilli found on respiratory and blood samples.
- CONTROL GROUP (HEALTHY VOLUNTEERS):
- No infection in the previous or current 30 days
- No fever reported in the previous 30 days
- No antibiotics taken in the previous 30 days
- Temperature < 37.8°C on the day of inclusion
- Absence of clinically suspected infection
- No surgery in the previous 30 days
- Patient over 18 years of age who has provided informed consent
- Patient affiliated to the national health insurance system
Who cannot join
- Person protected by law
- Minor
- Pregnant, parturient or breastfeeding woman
- Patient with a known primary or secondary immune deficiency (radiation therapy, chemotherapy, immunosuppressive therapy or systemic corticosteroid therapy (> 0.15 mg/kg/day of prednisone equivalent for more than 2 weeks or "bolus" higher than 2 mg/kg/day of prednisone equivalent in the 3 months prior to inclusion), HIV infection, primary cellular immune deficiency)
- Presenting a chronic disorder known to cause deep lymphopenia (Cirrhosis, lympho or myeloproliferative syndrome, solid cancer or active systemic lupus erythematosus) and/or a condition known to cause a substantial increase in INF-γ (active hepatitis B)
- Patient who was hospitalized in the 3 months prior to inclusion for sepsis according to the new SOFA quick criteria
Show all 10Show fewer
- Decision to limit care
- Treatment with Interferon initiated prior to study sampling
- For the pneumopathy group: Failure to take a sample for the QFM within 48 hours of admission.
- For the control group: CRP greater than 15 mg/L at the time of sampling
Trial locations and contacts
1 site in 1 country.
About this study
Lower respiratory infections, or pneumonia, remain the third leading cause of death worldwide, despite progress in vaccinating at-risk populations and improved resuscitation techniques.
Research shows that immune defences are weakened during severe infections. This immune weakening could alter resistance to bacterial infection and facilitate death, but also facilitate the onset of secondary infections.
Read more
Through this study, investigators wish to evaluate a biomedical test (derived from a blood sample - Quantiferon Monitor test), aimed at measuring the immune response of certain immune cells (lymphocytes).
The objective of the study is to determine whether this test can predict the occurrence of death during pneumonia.
If this hypothesis is verified, it would make it possible to use this test as a marker to identify patients at risk of death, and would open up new therapeutic prospects in order to provide patients with severe pneumonia with a treatment that stimulates their immune defences.
Recently, COVID-19 has changed the epidemiology and management of acute community-acquired pneumonia. Numerous studies, including some recently published ancillary studies of the Lymphony study, suggest that a deregulated immune response could contribute to the poor patient prognosis. Different determinants could contribute to this. Endotoxemia reflects the elevation of plasma LPS concentrations and represents a major Gram-negative determinant. Endotoxemia also seems to be observed during infectious pneumopathies, even though the main causative agents are devoid of LPS. The genesis of this endotoxemia and its intensity could reflect a digestive bacterial translocation phenomena that is correlated with severity.
Concerning the secondary objectives of the COVITOXEMIA ancillary study: the main hypothesis is that severe pneumopathies related to SARS-CoV2- are associated with endotoxemia.
Furthermore, early work comparing the immune response during severe SARS-CoV-2-related lung disease to immune responses of other origins demonstrated higher concentrations of CXCL10, GM-CSF, and VCAM1 during COVID-19. Since these 3 markers mediate activation (GM-CSF), chemotaxis (CXCL10), and diapedesis (VCAM-1) of myeloid cells, these results suggest an important role for their activation during COVID-19, especially of neutrophils.
Regarding the secondary objectives of the NETCovid study:
In an attempt to better characterize the specific pathogenesis of COVID-19, which contributes to the poor outcome, the objective is to compare the neutrophil immune response between patients with and without SARS-CoV-2 related severe pneumonia, considering the levels of biomarkers of activation (including NETose), degranulation and chemotaxis of neutrophils.
- Conditions
- Pneumonia
- Being tested
- Blood samples
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
Patients:
- 1 tube of 4 ml blood (Lithium Heparinate)
- 3 tubes of 7 ml blood (EDTA)
- 2 tubes of 7 ml blood (EDTA) for 20 NET Covid patients
Healthy volunteers:
- 1 tube of 4 ml blood (Lithium Heparinate)
- 3 tubes of 7 ml of blood (EDTA)
- 1 tube of 4 ml (citrate)
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Biological: Blood samples | |
| Healthy volunteers | Not described Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 30 days following hospitalization for community-acquired pneumonia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start5 Nov 2018
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 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
- NCT03505281
- Sponsor's protocol ID
- BLOT 2017 LYMPHONIE
- Acronym
- LYMPHONIE
- Status last verified
- Aug 2025
- First submitted
- 19 Apr 2018
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blot M, de Maistre E, Bourredjem A, Quenot JP, Nguyen M, Bouhemad B, Charles PE, Binquet C, Piroth L. Specific Features of the Coagulopathy Signature in Severe COVID-19 Pneumonia. Front Med (Lausanne). 2021 Aug 4;8:675191. doi: 10.3389/fmed.2021.675191. eCollection 2021.
PubMed 34422854Blot M, David Masson, Nguyen M, Bourredjem A; LYMPHONIE Study Group; Binquet C, Piroth L. Are adipokines the missing link between obesity, immune response, and outcomes in severe COVID-19? Int J Obes (Lond). 2021 Sep;45(9):2126-2131. doi: 10.1038/s41366-021-00868-5. Epub 2021 May 31.
PubMed 34059786Blot 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 33272291
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Functional Lymphocyte Test (QuantiFERON Monitor®) as a Prognostic Marker for Acute Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT03505281
- Acronym / sponsor ID
- LYMPHONIE / BLOT 2017 LYMPHONIE
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 23 Apr 2018 (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.
Lower respiratory infections, or pneumonia, remain the third leading cause of death worldwide, despite progress in vaccinating at-risk populations and improved resuscitation techniques.
Research shows that immune defences are weakened during severe infections. This immune weakening could alter resistance to bacterial infection and facilitate death, but also facilitate the onset of secondary infections.
Through this study, investigators wish to evaluate a biomedical test (derived from a blood sample - Quantiferon Monitor test), aimed at measuring the immune response of certain immune cells (lymphocytes).
The objective of the study is to determine whether this test can predict the occurrence of death during pneumonia.
If this hypothesis is verified, it would make it possible to use this test as a marker to identify patients at risk of death, and would open up new therapeutic prospects in order to provide patients with severe pneumonia with a treatment that stimulates their immune defences.
Recently, COVID-19 has changed the epidemiology and management of acute community-acquired pneumonia. Numerous studies, including some recently published ancillary studies of the Lymphony study, suggest that a deregulated immune response could contribute to the poor patient prognosis. Different determinants could contribute to this. Endotoxemia reflects the elevation of plasma LPS concentrations and represents a major Gram-negative determinant. Endotoxemia also seems to be observed during infectious pneumopathies, even though the main causative agents are devoid of LPS. The genesis of this endotoxemia and its intensity could reflect a digestive bacterial translocation phenomena that is correlated with severity.
Concerning the secondary objectives of the COVITOXEMIA ancillary study: the main hypothesis is that severe pneumopathies related to SARS-CoV2- are associated with endotoxemia.
Furthermore, early work comparing the immune response during severe SARS-CoV-2-related lung disease to immune responses of other origins demonstrated higher concentrations of CXCL10, GM-CSF, and VCAM1 during COVID-19. Since these 3 markers mediate activation (GM-CSF), chemotaxis (CXCL10), and diapedesis (VCAM-1) of myeloid cells, these results suggest an important role for their activation during COVID-19, especially of neutrophils.
Regarding the secondary objectives of the NETCovid study:
In an attempt to better characterize the specific pathogenesis of COVID-19, which contributes to the poor outcome, the objective is to compare the neutrophil immune response between patients with and without SARS-CoV-2 related severe pneumonia, considering the levels of biomarkers of activation (including NETose), degranulation and chemotaxis of neutrophils.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Biological: Blood samples |
| Healthy volunteers | – | Biological: Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute community-acquired pneumonia
Key inclusion criteria (28 listed)
- GROUP OF PATIENTS WITH PNEUMONIA
- Patient with acute pneumonitis:
- 1) Acute signs and symptoms of lung disease (new or worsening), including at least 2 of the following:
- Cough
- Dyspnea
Key exclusion criteria (10 listed)
- Person protected by law
- Minor
- Pregnant, parturient or breastfeeding woman
- Patient with a known primary or secondary immune deficiency (radiation therapy, chemotherapy, immunosuppressive therapy or systemic corticosteroid therapy (> 0.15 mg/kg/day of prednisone equivalent for more than 2 weeks or "bolus" higher than 2 mg/kg/day of prednisone equivalent in the 3 months prior to inclusion), HIV infection, primary cellular immune deficiency)
- Presenting a chronic disorder known to cause deep lymphopenia (Cirrhosis, lympho or myeloproliferative syndrome, solid cancer or active systemic lupus erythematosus) and/or a condition known to cause a substantial increase in INF-γ (active hepatitis B)
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 samplesPatients: * 1 tube of 4 ml blood (Lithium Heparinate) * 3 tubes of 7 ml blood (EDTA) * 2 tubes of 7 ml blood (EDTA) for 20 NET Covid patients Healthy volunteers: * 1 tube of 4 ml blood (Lithium Heparinate) * 3 tubes of 7 ml of blood (EDTA) * 1 tube of 4 ml (citrate) | Biological | Healthy volunteers, Patients |
Primary outcome
Death
Time frame: 30 days following hospitalization for community-acquired pneumonia
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 26 Aug 2025.
- Derived from this study: PubMed 34422854Blot M, de Maistre E, Bourredjem A, Quenot JP, Nguyen M, Bouhemad B, Charles PE, Binquet C, Piroth L. Specific Features of the Coagulopathy Signature in Severe COVID-19 Pneumonia. Front Med (Lausanne). 2021 Aug 4;8:675191. doi: 10.3389/fmed.2021.675191. eCollection 2021.
- Derived from this study: PubMed 34059786Blot M, David Masson, Nguyen M, Bourredjem A; LYMPHONIE Study Group; Binquet C, Piroth L. Are adipokines the missing link between obesity, immune response, and outcomes in severe COVID-19? Int J Obes (Lond). 2021 Sep;45(9):2126-2131. doi: 10.1038/s41366-021-00868-5. Epub 2021 May 31.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
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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 Pneumonia, 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 28 inclusion and 10 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 26 Aug 2025. 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?
Death (time frame: 30 days following hospitalization for community-acquired pneumonia). 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 NCT03505281, which also lists 3 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 26 Aug 2025.