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

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ClinicalTrials.gov Identifier: NCT03505281
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.


Condition or disease Intervention/treatment
Pneumonia Biological: Blood samples

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Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Functional Lymphocyte Test (QuantiFERON Monitor®) as a Prognostic Marker for Acute Community-acquired Pneumonia
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia


Intervention Details:
  • Biological: Blood samples
    Collection of two additional tubes at the time of a blood test necessary for patient follow-up.


Primary Outcome Measures :
  1. Death [ Time Frame: 30 days following hospitalization for community-acquired pneumonia ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute community-acquired pneumonia
Criteria

Inclusion Criteria:

  • Adult patient who has given consent
  • Presenting with acute community-acquired pneumonia:

    1. Acute signs and symptoms of pneumonia (at least one):

      New or worsening cough, Fever > 37.8 or hypothermia < 35.6°C, Abnormal leukocyte count (leukocytosis ≥ 10.106/L or < 4.106/L),

    2. and a new pulmonary radiological infiltrate (x-ray or CT scan at admission)
  • With at least 2 criteria of poor prognosis according to the SOFA quick score among the following:

systolic blood pressure ≤ 100 mm Hg, respiratory rate ≥ 22, altered consciousness (Glasgow score < 15)

Exclusion Criteria:

  • Adult protected by law
  • Minor
  • Patient not affiliated to a medical insurance scheme
  • Pregnant, parturient or breastfeeding woman
  • Patient with a known primary or secondary immune deficiency (radiation therapy, chemotherapy, immunosuppressive therapy or systemic corticosteroid therapy within 3 months prior to inclusion, HIV infection, primary cellular immune deficiency)
  • Presenting a chronic disorder known to cause deep lymphopenia (active cirrhosis, hematopathy or cancer) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505281


Contacts
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Contact: Mathieu BLOT 03.80.29.33.05 mathieu.blot@chu-dijon.fr

Locations
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France
Chu Dijon Bourogne Recruiting
Dijon, France, 21000
Contact: Mathieu BLOT    03.80.29.33.05    mathieu.blot@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03505281     History of Changes
Other Study ID Numbers: BLOT 2017 LYMPHONIE
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections