NCT03505281: LYMPHONIE

Evaluation of a Functional Lymphocyte Test (QuantiFERON Monitor®) as a Prognostic Marker for Acute Community-acquired Pneumonia

Completed Last updated 26 August 2025

What this trial tests

trial testing Blood samples in Pneumonia in 230 participants. Completed in 30 July 2025.

Timeline

5 November 2018

Primary endpoint
30 July 2025

30 July 2025

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Dijon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	230
Start date	5 November 2018
Primary completion	30 July 2025
Estimated completion	30 July 2025
Sites	1 location across France

Drugs / interventions tested

• Blood samples — full drug profile →

Conditions studied

• Pneumonia — all drugs for Pneumonia →

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

18 and older, any sex, with Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The dysregulated innate immune response in severe COVID-19 pneumonia that could drive poorer outcome.
   Blot M, Bour JB, Quenot JP, Bourredjem A, et al · · 2020 · cited 65× · PMID 33272291 · DOI 10.1186/s12967-020-02646-9
2. High plasma concentration of non-esterified polyunsaturated fatty acids is a specific feature of severe COVID-19 pneumonia.
   Nguyen M, Bourredjem A, Piroth L, Bouhemad B, et al · · 2021 · cited 24× · PMID 34031519 · DOI 10.1038/s41598-021-90362-9
3. Are adipokines the missing link between obesity, immune response, and outcomes in severe COVID-19?
   Blot M, David Masson, Nguyen M, Bourredjem A, et al · · 2021 · cited 17× · PMID 34059786 · DOI 10.1038/s41366-021-00868-5
4. Specific Features of the Coagulopathy Signature in Severe COVID-19 Pneumonia.
   Blot M, de Maistre E, Bourredjem A, Quenot JP, et al · · 2021 · cited 9× · PMID 34422854 · DOI 10.3389/fmed.2021.675191
5. Is IL-6 the Right Target in COVID-19 Severe Pneumonia?
   Blot M, Bourredjem A, Binquet C, Piroth L, et al · · 2021 · cited 7× · PMID 32955921 · DOI 10.1164/rccm.202007-2924le
6. Endotoxemia and its association with immune and coagulopathy responses in severe community-acquired pneumonia and COVID-19.
   Blot M, Sow AK, Masson D, Nguyen M, et al · · 2026 · PMID 41796408 · DOI 10.1186/s40635-026-00863-y
7. Pneumococcal meningitis and endotoxemia: A cross-sectional clinical study.
   Nguyen S, Godon J, de Barros JP, Masson D, et al · · 2025 · PMID 40397876 · DOI 10.1371/journal.pone.0324153
8. High Plasma Concentration of Non-Esterified Polyunsaturated Fatty Acids Is a Specific Feature of Severe COVID-19 Pneumonia
   Nguyen M, Bourredjem A, Piroth L, Bouhemad B, et al · · 2020 · DOI 10.2139/ssrn.3702938