Evaluating a blood test to predict outcomes in pneumonia patients

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

This study is testing a blood test to see if it can help doctors predict which pneumonia patients are at higher risk of dying so they can improve their treatment.

Quick facts

• Study type: Observational
• Enrollment: 212 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Dijon (Academic / other)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 1 site (Dijon)
• Trial ID: NCT03505281 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of the QuantiFERON Monitor test, which measures the immune response of lymphocytes through a blood sample, in predicting mortality in patients with acute community-acquired pneumonia. By analyzing the immune response during severe infections, the researchers hope to identify patients at higher risk of death and potentially improve treatment strategies. The study focuses on patients presenting with acute pneumonia symptoms and poor prognosis indicators. If successful, this could lead to new therapeutic approaches that enhance immune function in these patients.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with acute community-acquired pneumonia exhibiting severe symptoms and poor prognosis indicators.

Not a fit: Patients with mild pneumonia or those not meeting the severe prognosis criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this test could help identify pneumonia patients at risk of death, allowing for timely and targeted interventions.

How similar studies have performed: While there have been studies on immune responses in pneumonia, the specific use of the QuantiFERON Monitor test as a prognostic marker is novel and untested.

Eligibility criteria

Inclusion Criteria:

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
* 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":

  1. Respiratory specimen positive for SARS-CoV-2 (PCR)
  2. And without Gram-negative bacilli found on respiratory and blood samples.

CONTROL GROUP (HEALTHY VOLUNTEERS):

* No infection in the previous or current 30 days

  1. No fever reported in the previous 30 days
  2. No antibiotics taken in the previous 30 days
  3. Temperature \< 37.8°C on the day of inclusion
  4. 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

Exclusion Criteria:

* 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
* Decision to limit care
* Treatment with Interferon initiated prior to study sampling

EXCLUSION CRITERIA

* 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

Where this trial is running

Dijon

• Chu Dijon Bourogne — Dijon, France (Recruiting)

Study contacts

• Study coordinator: Mathieu BLOT

Conditions Pneumonia