Clinical trial NCT05582239: Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults
Official title: Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Acute Respiratory Infection (SARI)
Influenza
COVID-19
Keywords: Severe acute respiratory infection (SARI)
Vaccine effectiveness
Influenza
COVID-19
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: P95
name: I-REIVAC
name: EPICONCEPT
name: Institut de Recherche en Santé Publique, France
First posted: 2022-10-17
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients presenting with SARI symptom onset in the first 14 days

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vaccine effectiveness
timeFrame: up to 48 hours
Secondary outcomes:
measure: Covid-19 vaccine effectiveness
timeFrame: up to 48 hours
measure: Influenza vaccine effectiveness
timeFrame: up to 48 hours
measure: Prevalence of viral and bacterial co-infections
timeFrame: up to 48 hours
measure: Incidence of SARI by site
timeFrame: up to 12 months
measure: Clinical burden of SARI
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU
city: Lyon
country: France
facility: Groupement hospitalier Edouard Herriot
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Nantes
country: France
facility: CHU
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Bichat
city: Rennes
country: France
facility: CHU
city: Saint-Étienne
country: France
facility: CHU
Study officials:
References: