InfluenzaCHOPINNCT06254313
The Role of Cxcr4Hi neutrOPhils in InflueNza
An observational study of Influenza and Acute Respiratory Distress Syndrome, run by University Hospital, Bordeaux at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Acute Respiratory Distress Syndrome
- What is being tested?
- Additional tubes and LBA
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of interest will be patients with acute respiratory distress syndrome according to the Berlin criteria.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Out-of-control shock.
- Intracranial high pressure.
- Refractory hypoxemia (PaO2/FiO2 < 60 mmHg).
- Legal restriction: prisoners, pregnancy, legal protection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hopital Pellegrin
Bordeaux, 33000
Renaud PREVEL, Dr, 5 57 87 26 26 ext. +33, renaud.prevel@u-bordeaux.fr
- Not yet recruiting
Hopital Haut-Lévêque
Pessac, 33604
Antoine DEWITTE, Dr, antoine.dewitte@u-bordeaux.fr
About this study
Official title: The Role of CXCR4-expressing Neutrophils in Influenza-related Acute Respiratory Distress Syndrome
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.
Read the detailed description
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. Most of severe influenza patients suffer from acute lung injury due to a dysregulated immune response. Neutrophils are involved in both host resistance and disease tolerance. Thanks to advances in technologies, the vast variety in neutrophils subpopulations has been revealed. In particular, the subpopulation of CXCR4-expressing neutrophils has been suggested to be involved in the rupture of disease tolerance in lung infections. Nevertheless, these data are from murine models and remain to be confirmed in humans. Moreover, the underlying mechanisms remain unknown as well as the place of primum movens, i.e. vascular or alveolar compartment. The aim of this study is thus to compare the percentage of blood CXCR4-expressing neutrophils between influenza survivors and non-survivors. Percentage of BAL CXCR4-expressing neutrophils will also be compared. To this aim, blood sampling and BAL within the 24 hours and at day 3 after admission to ICU, neutrophils isolation, immunostaining and flow cytometry acquisition will be performed within the 24 hours and at day 3 after admission to ICU. Mortality rate will be collected at Day 28 and Day 90.
- Conditions
- Influenza, Acute Respiratory Distress Syndrome
- Being tested
- Additional tubes and LBA
- Keywords
- neutrophils, CXCR4, host resistance, disease tolerance
- Medical subject headings
- Influenza, Human, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional tubes and LBAOther
4 Additional tubes taken when blood is drawn during treatment : EDTA tubes and 2 citrate tubes and bronchoalveolar fluid sample (LBA)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Additional tubes and LBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological
Percentage of blood CXCR4-expressing neutrophils within the 24 hours following admission to ICU for invasive mechanical ventilation.
Measured: Day 1 after inclusion
Clinical
Mortality
Measured: Day 28 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard LHOMME, Dr, Study chair, Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254313
- Sponsor's protocol ID
- CHUBX 2023/41
- Acronym
- CHOPIN
- Status last verified
- Dec 2024
- First submitted
- 2 Feb 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of CXCR4-expressing Neutrophils in Influenza-related Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06254313
- Acronym / sponsor ID
- CHOPIN / CHUBX 2023/41
- Conditions
- Influenza, Acute Respiratory Distress Syndrome
- Keywords
- neutrophils, CXCR4, host resistance, disease tolerance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Most of severe influenza patients suffer from acute lung injury due to a dysregulated immune response. Neutrophils are involved in both host resistance and disease tolerance. Thanks to advances in technologies, the vast variety in neutrophils subpopulations has been revealed. In particular, the subpopulation of CXCR4-expressing neutrophils has been suggested to be involved in the rupture of disease tolerance in lung infections. Nevertheless, these data are from murine models and remain to be confirmed in humans. Moreover, the underlying mechanisms remain unknown as well as the place of primum movens, i.e. vascular or alveolar compartment. The aim of this study is thus to compare the percentage of blood CXCR4-expressing neutrophils between influenza survivors and non-survivors. Percentage of BAL CXCR4-expressing neutrophils will also be compared. To this aim, blood sampling and BAL within the 24 hours and at day 3 after admission to ICU, neutrophils isolation, immunostaining and flow cytometry acquisition will be performed within the 24 hours and at day 3 after admission to ICU. Mortality rate will be collected at Day 28 and Day 90.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Influenza-related ARDS group | – | Other: Additional tubes and LBAPerson 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. |
| Bacterial-related ARDS group | – | Other: Additional tubes and LBAA 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. |
| Extra-pulmonary (digestive inflammation) ARDS group | – | Other: Additional tubes and LBAPerson 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of interest will be patients with acute respiratory distress syndrome according to the Berlin criteria.
Key inclusion criteria (10 listed)
- 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:
- Health insurance.
Key exclusion criteria (10 listed)
- Neutropenia (< 500/mm3)
- Neutrophils qualitative defect.
- Patient included in an interventional research assessing an immunomodulatory or antiviral drug.
- Acquired ImmunoDeficiency Syndrome.
- Contraindication to BAL:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional tubes and LBA4 Additional tubes taken when blood is drawn during treatment : EDTA tubes and 2 citrate tubes and bronchoalveolar fluid sample (LBA) | Other | Bacterial-related ARDS group, Extra-pulmonary (digestive inflammation) ARDS group, Influenza-related ARDS group |
Primary outcome
Biological
Time frame: Day 1 after inclusion
Percentage of blood CXCR4-expressing neutrophils within the 24 hours following admission to ICU for invasive mechanical ventilation.
Clinical
Time frame: Day 28 after inclusion
Mortality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edouard LHOMME, Dr study chair
Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Acute Respiratory Distress Syndrome, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renaud PREVEL, Dr (5 57 87 26 26 ext. +33, renaud.prevel@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological (time frame: Day 1 after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.