Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| P95 | INDUSTRY |
| I-REIVAC | UNKNOWN |
| EPICONCEPT | UNKNOWN |
| Institut de Recherche en Santé Publique, France |
Not provided
Not provided
Not provided
Not provided
This study is a prospective, multicentric, observational test negative design study on adults hospitalized for Severe Acute Respiratory Infection (SARI), regardless of their vaccination status.
Participation to the study will be systematically proposed to all patients hospitalized fitting inclusion criteria. Patient's screening will be done in emergency department or hospital department with direct admission. Medical investigators explain the objectives of the studies, procedure and propose the patient to participate in the study. Socio-demographic data, clinical and virological data will be collected in an electronic clinical research form.
A follow-up at 1 and 3 months after hospitalization discharge will be scheduled to evaluate health status.
The remainder of respiratory samples that have been performed for care will be used for further testing depending on epidemiological situation and will be stored at -80°C.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine effectiveness | Comparison of the number of virologically confirmed cases of vaccine preventable Severe Acute Respiratory Infections (SARI) among hospitalized vaccinated patients compared with unvaccinated patients. | up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Covid-19 vaccine effectiveness | Comparison of numbers of hospitalized cases with documented COVID-19 infection in vaccinated and unvaccinated patients according to:
| up to 48 hours |
| Influenza vaccine effectiveness |
Not provided
Inclusion Criteria:
At least one of the following signs (without treatment): fever or feverishness, malaise, headache, myalgia or sign of fatigue (loss of weight or anorexia or confusion or dizziness) Associated with at least one respiratory symptom or sign (cough, sore throat or shortness of breath; or tachypnoea or signs of low oxygen saturation)
Exclusion Criteria:
Not provided
Not provided
Not provided
Hospitalized patients presenting with SARI symptom onset in the first 14 days
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Rekacewicz, MD | Contact | + 33 1 42 34 83 75 | claire.rekacewicz@inserm.fr | |
| Mohamed Ben Mechlia, PhD | Contact | + 33 1 44 23 61 38 | mohamed.ben-mechlia@anrs.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Recruiting | Dijon | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Swab respiratory samples
Comparison of numbers of hospitalized cases with documented flu in vaccinated and unvaccinated according to:
|
| up to 48 hours |
| Prevalence of viral and bacterial co-infections | Prevalence of other viruses and bacteria detected by PCR, antigen tests, microbiology samples. | up to 48 hours |
| Incidence of SARI by site | Incidence rate of SARI by sites | up to 12 months |
| Clinical burden of SARI | European Quality of Life by 5 Dimension (EQ5D) score assessed at 1 month and 3 months after hospitalization discharge. Scale from 0 to 100 with 0 corresponding to the worst quality of life. | up to 3 months |
| Groupement hospitalier Edouard Herriot | Recruiting | Lyon | France |
|
| Hôpital Gui de Chauliac | Recruiting | Montpellier | France |
|
| CHU | Recruiting | Nantes | France |
|
| Hôpital Cochin | Recruiting | Paris | 75014 | France |
|
| Hôpital Bichat | Recruiting | Paris | France |
|
| CHU | Recruiting | Rennes | France |
|
| CHU | Recruiting | Saint-Etienne | France |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |