Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults

ANRS, Emerging Infectious Diseases2,400 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,400

Conditions

Severe Acute Respiratory Infection (SARI)Influenza COVID-19

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

CHU

Dijon, France

RECRUITING

Groupement hospitalier Edouard Herriot

Lyon, France

RECRUITING

Hôpital Gui de Chauliac

Montpellier, France

Outcomes

Primary Outcomes

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.

Time frame: up to 48 hours

Secondary Outcomes

Covid-19 vaccine effectiveness

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

Time frame: up to 48 hours

Influenza vaccine effectiveness

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

Time frame: up to 48 hours

Prevalence of viral and bacterial co-infections

Prevalence of other viruses and bacteria detected by PCR, antigen tests, microbiology samples.

Time frame: up to 48 hours

Incidence of SARI by site

Incidence rate of SARI by sites

Time frame: 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.

Time frame: up to 3 months

Central Contacts

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

Data from ClinicalTrials.gov

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