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

NCT ID: NCT05582239

Last Updated: 2023-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-20

Study Completion Date

2026-01-20

Brief Summary

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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

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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.

Conditions

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Severe Acute Respiratory Infection (SARI) Influenza COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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P95

INDUSTRY

Sponsor Role collaborator

I-REIVAC

UNKNOWN

Sponsor Role collaborator

EPICONCEPT

UNKNOWN

Sponsor Role collaborator

Institut de Recherche en Santé Publique, France

OTHER

Sponsor Role collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU

Dijon, , France

Site Status RECRUITING

Groupement hospitalier Edouard Herriot

Lyon, , France

Site Status RECRUITING

Hôpital Gui de Chauliac

Montpellier, , France

Site Status RECRUITING

CHU

Nantes, , France

Site Status RECRUITING

Hôpital Cochin

Paris, , France

Site Status RECRUITING

Hôpital Bichat

Paris, , France

Site Status RECRUITING

CHU

Rennes, , France

Site Status RECRUITING

CHU

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Claire Rekacewicz, MD

Role: CONTACT

+ 33 1 42 34 83 75

Mohamed Ben Mechlia, PhD

Role: CONTACT

+ 33 1 44 23 61 38

Other Identifiers

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ANRS0285s

Identifier Type: -

Identifier Source: org_study_id

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