NCT06720818

Brief Summary

Viral pneumonia, including SARS-CoV-2 and influenza A virus (IAV), can culminate in acute respiratory distress syndrome (ARDS), a severe form of respiratory failure with high mortality. Uncontrolled local inflammatory response and impaired tissue repair are hallmarks of ARDS. However, lack of in-depth understanding of the immunopathology lead to limited identification of potential 'endotypes' who may benefit from individualized targeted therapies. Mucosal Associated Invariant T (MAIT) cells represent a peculiar lineage of T cells with a wide panel of effector functions. Thus, they emerge as potential key players and appealing targets in ARDS through their potent abilities to modulate immune response at barrier sites and promote tissue repair. Recent data from the investigators and others indicated that MAIT cells are highly activated in patients with Sars-Cov-2 and IAV ARDS, but the associated activation mechanisms and precise functions remain unknown. In this context, the investigators aim at investigating the implication and potential harnessing of MAIT cells in severe viral pneumonias and associated ARDS by with a dedicated clinical study. First, the investigators will perform a comprehensive and longitudinal phenotyping of immune response during viral pneumonia-induced ARDS, including MAIT cells, in blood -and airway compartment for mechanically ventilated patients. To provide more insight into specificity of virally induced pneumonia and ARDS, longitudinal phenotyping of immune response of patients with bacterial pneumonia, and control patients with unrelated ARDS (severe trauma, pancreatitis or major surgery) will also be performed.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
34mo left

Started May 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
May 2025Feb 2029

First Submitted

Initial submission to the registry

November 25, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

3.7 years

First QC Date

November 25, 2024

Last Update Submit

May 22, 2025

Conditions

Keywords

Mucosal Associated Invariant T cellphysiopathologyimmune response

Outcome Measures

Primary Outcomes (1)

  • MAIT cells frequency during pneumonia and ARDS

    MAIT cell frequency will be determined as % of CD3+ cells using flow cytometry techniques on biological samples obtained from samples done during routine care of patients included in the study (blood samples, and tracheal aspiration and broncho alveolar lavage for mechanically ventilated patients).

    Blood and airway (tracheal aspiration or bronchoalveolar lavage, for patients under mechanical ventilation) will be sampled and analyzed at inclusion, day 3, day 5 and every week until ICU discharge (with a maximum of 90 days in ICU after inclusion)

Secondary Outcomes (1)

  • Activation of MAIT cells during severe pneumonia and ARDS

    Blood and airway (tracheal aspiration or bronchoalveolar lavage, for patients under mechanical ventilation) will be sampled and analyzed at inclusion, day 3, day 5 and every week until discharge (with a maximum of 90 days in ICU after inclusion).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to critical care units at the CHRU de Tours for different reasons

You may qualify if:

  • Age ≥ 18 years
  • Patients admitted to critical care (Intensive Care Unit, Continuous Monitoring Unit, Intensive Care Unit) at the CHRU de Tours
  • Patients admitted to critical care for one of the following reasons:
  • Acute community-acquired pulmonary infection (pneumonia),
  • Severe acute pancreatitis, with onset of ARDS criteria less than 48 hours ago,
  • Severe isolated head injury requiring invasive mechanical ventilation,
  • Severe burn defined by a burned surface area exceeding 20% and/or deep lesions exceeding 3% of the total body surface area, with the onset of ARDS criteria less than 48 hours ago,
  • Patient admitted to Intensive Care Medicine, requiring invasive mechanical ventilation,
  • Patients with severe immunosuppression (impairing the ability to analyse the immune response, particularly T lymphocytes): active haematological malignancy, solid organ transplantation or bone marrow transplantation, systemic immunosuppressive treatment, ongoing chemotherapy (including immune checkpoint inhibitors).
  • Person who has objected to data processing
  • Patient under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Tours, 37044, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and respiratory samples

MeSH Terms

Conditions

Pneumonia, ViralRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Youenn JOUAN, Dr

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 25, 2024

First Posted

December 6, 2024

Study Start

May 5, 2025

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations