The Role of Cxcr4Hi neutrOPhils in InflueNza

NCT06254313 | Recruiting

• 1 other identifier: CHUBX 2023/41
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Influenza is still responsible for more than 650,000 deaths per year worldwide and no major improvements in patients' care has been made despite 50 years of research. Especially, there is no therapeutic strategy targeting the dysregulated host response. CXCR4-expressing neutrophils seem to be involved in the rupture of host resistance. The aim of this study is thus to compare the percentage of blood CXCR4-expressing neutrophils between influenza survivors and non-survivors.

Conditions

Influenza; Acute Respiratory Distress Syndrome

Keywords

neutrophils; CXCR4; host resistance; disease tolerance

Outcome Measures

Primary Outcomes (2)

• Biological

  Percentage of blood CXCR4-expressing neutrophils within the 24 hours following admission to ICU for invasive mechanical ventilation.

  Day 1 after inclusion

• Clinical

  Mortality

  Day 28 after inclusion

Study Arms (3)

Influenza-related ARDS group

Person with influenza virus infection proven by a positive polymerase chain reaction test for the influenza ARDS group. Additional tubes taken when blood is drawn during treatment, and bronchoalveolar fluid sample.

Other: Additional tubes and LBA

Bacterial-related ARDS group

A person with a proven bacterial infection (105 colony-forming units/mL for tracheal aspirates and more than 104 colony-forming units/mL for BAL). Additional tubes taken when blood is drawn during treatment, and bronchoalveolar fluid sample.

Other: Additional tubes and LBA

Extra-pulmonary (digestive inflammation) ARDS group

Person presenting with acute pancreatitis according to the 2013 international recommendations (typical pain, lipasemia above 3 times normal and/or abnormality on imaging). Or Person presenting with acute bacterial peritonitis based on a clinical diagnosis and bacteria isolated on peritoneal samples (RFE SFAR 2018). Additional tubes taken when blood is drawn during treatment, and bronchoalveolar fluid sample.

Other: Additional tubes and LBA

Interventions

Additional tubes and LBA OTHER

4 Additional tubes taken when blood is drawn during treatment : EDTA tubes and 2 citrate tubes and bronchoalveolar fluid sample (LBA)

Bacterial-related ARDS group; Extra-pulmonary (digestive inflammation) ARDS group; Influenza-related ARDS group

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

The population of interest will be patients with acute respiratory distress syndrome according to the Berlin criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

Hopital Pellegrin

Bordeaux, 33000, France

RECRUITING

Hopital Haut-Lévêque

Pessac, 33604, France

NOT YET RECRUITING

MeSH Terms

Conditions

Influenza, Human; Respiratory Distress Syndrome

Interventions

LRBA protein, human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders

Study Officials

• Edouard LHOMME, Dr

  Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux

  STUDY CHAIR

Central Study Contacts

Renaud PREVEL, Dr

CONTACT

5 57 87 26 26; renaud.prevel@u-bordeaux.fr

Study Design

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

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

FR (2)