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

NCT03505281 | Completed

• 1 other identifier: BLOT 2017 LYMPHONIE
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• Death

  30 days following hospitalization for community-acquired pneumonia

Study Arms (2)

Patients

Biological: Blood samples

Healthy volunteers

Biological: Blood samples

Interventions

Blood samples BIOLOGICAL

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)

Healthy volunteers; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute community-acquired pneumonia

You may qualify if:

• GROUP OF PATIENTS WITH PNEUMONIA
• Patient with acute pneumonitis:
• \) Acute signs and symptoms of lung disease (new or worsening), including at least 2 of the following:
• Cough
• Dyspnea
• Purulent sputum
• 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

You may not qualify if:

• Person protected by law
• Minor
• Pregnant, parturient or breastfeeding woman
• 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)
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (3)

• 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.

  PMID: 34422854 DERIVED

• Blot 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.

  PMID: 34059786 DERIVED

• 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.

  PMID: 33272291 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: April 23, 2018
• Study Start: November 5, 2018
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)