InfluenzaANTIGRIPPENCT02392858
Severe Influenza Cohort
A study testing influenza cohort in people with Influenza and Severe Respiratory Infection, run by Hospices Civils de Lyon at 15 sites in France.
Trial summary
Influenza is a major cause of morbidity and mortality. The investigators first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Read more about this study
- Who is it for?
- Ages 1 month to 99 years
- Conditions the study is for
- Influenza, Severe Respiratory Infection
- What is being tested?
- influenza cohort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 15 sitesFrance
- Study dates
- 16 Jan 2015to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 month to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient (Adult or Pediatric)
- Hospitalized in reanimation
- With a laboratory confirmed Influenza
- That agree to take part in the study
- Affiliated to National Health Insurance
- For ancillary group :
- Adult at least 60 years old
- Presenting at hospital for a blood test
Who cannot join
- non willing to participate
- Influenza infection with no respiratory symptoms
- pregnancy
- For ancillary group :
- Presence of immunodepression defined by:
- Cancer, or cancer cured for less than 2 years
- Corticosteroids, Methotrexate (MTX), anti Tumor Necrosis Factor (TNF), anti-CD20
- Infection in progress (fever)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Hôpital Femme Mère Enfant
Bron
CHU service réanimation adulte
Clermont-Ferrand
CHU service réanimation pédiatrique
Clermont-Ferrand
CHU service réanimation adulte
Dijon
CHU service réanimation pédiatrique
Dijon
CHU service réanimation adulte
Grenoble
CHU service réanimation pédiatrique
Grenoble
Centre de Biologie et de Pathologie Nord
Lyon, Auvergne-Rhône-Alpes, 69500
Centre de Biologie et Pathologie Est
Lyon
Hôpital de la Croix Rousse-service réanimation adulte chirurgicale
Lyon
Hôpital de la Croix Rousse-service réanimation adulte médicale
Lyon
Hôpital Edouard Herriot
Lyon
Centre Hospitalier Lyon Sud
Pierre-Bénite
CHU Service de Réanimation Adulte
Saint-Etienne
CHU Service de Réanimation Pédiatrique
Saint-Etienne
About this study
Official title: Identification, in Patients Admitted to Intensive Care for Severe Influenza Respiratory Infection, of a Predictive Biomarker of Respiratory Distress
Influenza is a major cause of morbidity and mortality. The investigators first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.
- Conditions
- Influenza, Severe Respiratory Infection
- Being tested
- influenza cohort
- Medical subject headings
- Influenza, Human, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza cohortOther
Influenza is a major cause of morbidity and mortality. The investigators' first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.
| Study group | Role | What they receive |
|---|---|---|
| influenza cohort | Other | Influenza is a major cause of morbidity and mortality. The investigators' first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation.
1 control group of 30 patients (ancillary study) will be constitued to have reference values of the HLA-G5 marker.
Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms. Receives: Other: influenza cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ratio of the partial pressure of oxygen in arterial blood (PaO2) to the inspired oxygen fraction (FiO2), from admission at 7 days post-admission
decreased arterial PaO2/FiO2 ratio ≤ 100 mmHg (≤ 13.3 kPa)
Measured: The first, third, fifth and seventh day of hospitalization in reanimation
Secondary outcomes (3)
All cause mortality
Measured: 90 days after hospitalization
Extracorporeal membrane oxygenation requirement
Measured: 90 days after hospitalization
SOFA score (Adult) PELOD (Pediatric)
Elevated Score is considered as an evidence of clinical gravity
Measured: The first, third, fifth and seventh day of hospitalization in reanimation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start16 Jan 2015
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Sebastien CASALEGNO, MD/PhD, Principal investigator, HOSPICES CIVILS DE LYON, Virology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392858
- Sponsor's protocol ID
- 2014-A01023-44
- Acronym
- ANTIGRIPPE
- Status last verified
- Nov 2025
- First submitted
- 4 Mar 2015
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang Q, Pizzorno A, Miorin L, Bastard P, Gervais A, Le Voyer T, Bizien L, Manry J, Rosain J, Philippot Q, Goavec K, Padey B, Cupic A, Laurent E, Saker K, Vanker M, Sarekannu K; COVID Human Genetic Effort; Etablissement Francais du Sang Study Group; Constances Cohort; 3C-Dijon Study; Cerba HealthCare Group; Lyon Antigrippe Working Group; REIPI INF Working Group; Garcia-Salum T, Ferres M, Le Corre N, Sanchez-Cespedes J, Balsera-Manzanero M, Carratala J, Retamar-Gentil P, Abelenda-Alonso G, Valiente A, Tiberghien P, Zins M, Debette S, Meyts I, Haerynck F, Castagnoli R, Notarangelo LD, Gonzalez-Granado LI, Dominguez-Pinilla N, Andreakos E, Triantafyllia V, Rodriguez-Gallego C, Sole-Violan J, Ruiz-Hernandez JJ, Rodriguez de Castro F, Ferreres J, Briones M, Wauters J, Vanderbeke L, Feys S, Kuo CY, Lei WT, Ku CL, Tal G, Etzioni A, Hanna S, Fournet T, Casalegno JS, Queromes G, Argaud L, Javouhey E, Rosa-Calatrava M, Cordero E, Aydillo T, Medina RA, Kisand K, Puel A, Jouanguy E, Abel L, Cobat A, Trouillet-Assant S, Garcia-Sastre A, Casanova JL. Autoantibodies against type I IFNs in patients with critical influenza pneumonia. J Exp Med. 2022 Nov 7;219(11):e20220514. doi: 10.1084/jem.20220514. Epub 2022 Sep 16.
PubMed 36112363
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification, in Patients Admitted to Intensive Care for Severe Influenza Respiratory Infection, of a Predictive Biomarker of Respiratory Distress
- ClinicalTrials.gov ID
- NCT02392858
- Acronym / sponsor ID
- ANTIGRIPPE / 2014-A01023-44
- Conditions
- Influenza, Severe Respiratory Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Jan 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 19 Mar 2015 (estimated)
- 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 a major cause of morbidity and mortality. The investigators first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| influenza cohort | Other | Other: influenza cohortInfluenza is a major cause of morbidity and mortality. The investigators' first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. 1 control group of 30 patients (ancillary study) will be constitued to have reference values of the HLA-G5 marker. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms. |
Who may qualify
- Ages
- 1 month to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patient (Adult or Pediatric)
- Hospitalized in reanimation
- With a laboratory confirmed Influenza
- That agree to take part in the study
- Affiliated to National Health Insurance
Key exclusion criteria (8 listed)
- non willing to participate
- Influenza infection with no respiratory symptoms
- pregnancy
- Presence of immunodepression defined by:
- Infection in progress (fever)
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 |
|---|---|---|
| influenza cohortInfluenza is a major cause of morbidity and mortality. The investigators' first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms. | Other | influenza cohort |
Primary outcome
Change in ratio of the partial pressure of oxygen in arterial blood (PaO2) to the inspired oxygen fraction (FiO2), from admission at 7 days post-admission
Time frame: The first, third, fifth and seventh day of hospitalization in reanimation
decreased arterial PaO2/FiO2 ratio ≤ 100 mmHg (≤ 13.3 kPa)
3 secondary outcomes
All cause mortality
Time frame: 90 days after hospitalization
Extracorporeal membrane oxygenation requirement
Time frame: 90 days after hospitalization
SOFA score (Adult) PELOD (Pediatric)
Time frame: The first, third, fifth and seventh day of hospitalization in reanimation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 36112363Zhang Q, Pizzorno A, Miorin L, Bastard P, Gervais A, Le Voyer T, Bizien L, Manry J, Rosain J, Philippot Q, Goavec K, Padey B, Cupic A, Laurent E, Saker K, Vanker M, Sarekannu K; COVID Human Genetic Effort; Etablissement Francais du Sang Study Group; Constances Cohort; 3C-Dijon Study; Cerba HealthCare Group; Lyon Antigrippe Working Group; REIPI INF Working Group; Garcia-Salum T, Ferres M, Le Corre N, Sanchez-Cespedes J, Balsera-Manzanero M, Carratala J, Retamar-Gentil P, Abelenda-Alonso G, Valiente A, Tiberghien P, Zins M, Debette S, Meyts I, Haerynck F, Castagnoli R, Notarangelo LD, Gonzalez-Granado LI, Dominguez-Pinilla N, Andreakos E, Triantafyllia V, Rodriguez-Gallego C, Sole-Violan J, Ruiz-Hernandez JJ, Rodriguez de Castro F, Ferreres J, Briones M, Wauters J, Vanderbeke L, Feys S, Kuo CY, Lei WT, Ku CL, Tal G, Etzioni A, Hanna S, Fournet T, Casalegno JS, Queromes G, Argaud L, Javouhey E, Rosa-Calatrava M, Cordero E, Aydillo T, Medina RA, Kisand K, Puel A, Jouanguy E, Abel L, Cobat A, Trouillet-Assant S, Garcia-Sastre A, Casanova JL. Autoantibodies against type I IFNs in patients with critical influenza pneumonia. J Exp Med. 2022 Nov 7;219(11):e20220514. doi: 10.1084/jem.20220514. Epub 2022 Sep 16.
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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. This study is not recruiting at the moment.
Jean-Sebastien CASALEGNO, MD/PhD principal investigator
HOSPICES CIVILS DE LYON, Virology Department
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing influenza cohort in people with Influenza and Severe Respiratory Infection, run by Hospices Civils de Lyon at 15 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ratio of the partial pressure of oxygen in arterial blood (PaO2) to the inspired oxygen fraction (FiO2), from admission at 7 days post-admission (time frame: The first, third, fifth and seventh day of hospitalization in reanimation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392858, which also lists 1 linked publication.
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 4 Dec 2025.