Investigating the role of specific neutrophils in influenza outcomes
The Role of CXCR4-expressing Neutrophils in Influenza-related Acute Respiratory Distress Syndrome
This study is trying to see if certain types of white blood cells in people with severe influenza can help explain why some patients survive while others do not.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 2 sites (Bordeaux and 1 other locations) |
| Trial ID | NCT06254313 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the percentage of CXCR4-expressing neutrophils in the blood of influenza survivors and non-survivors. It focuses on understanding the role of these neutrophils in the immune response to influenza, particularly in patients with acute respiratory distress syndrome. Blood samples and bronchoalveolar lavage (BAL) will be collected within 24 hours and on day 3 after ICU admission to analyze neutrophil populations using immunostaining and flow cytometry. The study will also track mortality rates at 28 and 90 days post-admission.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute respiratory distress syndrome caused by influenza or certain bacterial infections.
Not a fit: Patients with neutropenia, significant neutrophil defects, or those receiving immunomodulatory treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies targeting the immune response in influenza patients.
How similar studies have performed: While this approach is based on murine models, it remains to be confirmed in human studies, indicating a novel exploration in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 18 yo or above. * Acute respiratory distress syndrome as defined by the Berlin classification. * Invasive mechanical ventilation for less than 24 hours. * Cause of ARDS: * Influenza infection proven by polymerase chain reaction OR * Bacterial infection (tracheal aspirate with more than 105 CFU/mL and BAL with more than 104 CFU/mL. * Pancreatitis according to the 2013 Working Group IAP/APA Acute Pancreatitis Guidelines. * Peritonitis according to the 2018 SFAR guidelines. * Health insurance. * Written informed consent from legal relative or representative. Exclusion Criteria: * Neutropenia (\< 500/mm3) * Neutrophils qualitative defect. * Patient included in an interventional research assessing an immunomodulatory or antiviral drug. * Acquired ImmunoDeficiency Syndrome. * Contraindication to BAL: * Severe bronshospasm. * Out-of-control shock. * Intracranial high pressure. * Refractory hypoxemia (PaO2/FiO2 \< 60 mmHg). * Legal restriction: prisoners, pregnancy, legal protection.
Where this trial is running
Bordeaux and 1 other locations
- Hopital Pellegrin — Bordeaux, France (Recruiting)
- Hopital Haut-Lévêque — Pessac, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Renaud PREVEL, Dr
- Email: renaud.prevel@u-bordeaux.fr
- Phone: 5 57 87 26 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.