COVID-19, Influenza, Severe Acute Respiratory Infection (SARI)
Conditions
Keywords
Severe acute respiratory infection (SARI), Vaccine effectiveness, Influenza, COVID-19
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
P95
I-REIVAC
EPICONCEPT
Institut de Recherche en Santé Publique, France
ANRS, Emerging Infectious Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Admitted in a hospital for at least 24 h * Presents SARI criteria within onset within the last 14 days before sampling and less than 48 h after hospitalisations: 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) * completed non-opposition form * Respiratory samples within 14 days after symptoms onset, in the context of care
Exclusion criteria
* Contraindication of vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine effectiveness | up to 48 hours | Comparison of the number of virologically confirmed cases of vaccine preventable Severe Acute Respiratory Infections (SARI) among hospitalized vaccinated patients compared with unvaccinated patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Covid-19 vaccine effectiveness | up to 48 hours | Comparison of numbers of hospitalized cases with documented COVID-19 infection in vaccinated and unvaccinated patients according to: * Age * comorbidities * Vaccine schedule (numbers of doses and brand) * date of vaccination * SARS-CoV-2 Variant |
| Influenza vaccine effectiveness | up to 48 hours | Comparison of numbers of hospitalized cases with documented flu in vaccinated and unvaccinated according to: * Age * Comorbidities * Vaccine brand * Date of vaccination * Previous vaccination * Viral strain |
| Prevalence of viral and bacterial co-infections | up to 48 hours | Prevalence of other viruses and bacteria detected by PCR, antigen tests, microbiology samples. |
| Incidence of SARI by site | up to 12 months | Incidence rate of SARI by sites |
| Clinical burden of SARI | up to 3 months | 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. |
Countries
France
Contacts
Primary ContactClaire Rekacewicz, MD
Backup ContactMohamed Ben Mechlia, PhD
Outcome results
None listed