Severe Acute Respiratory Infection (SARI)RESPIVACNCT05582239
Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults
An observational study of Severe Acute Respiratory Infection (SARI) and Influenza, run by ANRS, Emerging Infectious Diseases at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Infection (SARI), Influenza, COVID-19
- How many people
- 2,400 participants
- Where
- 8 sitesFrance
- Study dates
- 20 Jan 2023to 20 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients presenting with SARI symptom onset in the first 14 days
Who may be able to join
- 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
Who cannot join
- Contraindication of vaccination
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
CHU
Dijon
Lionel PIROTH, MD
- Recruiting
Groupement hospitalier Edouard Herriot
Lyon
Philippe VANHEMS, MD
- Recruiting
Hôpital Gui de Chauliac
Montpellier
Florence GALTIER, MD
- Recruiting
CHU
Nantes
Maëva LEFEBVRE, MD
- Recruiting
Hôpital Cochin
Paris, 75014
Liem LUONG, MD
- Recruiting
Hôpital Bichat
Paris
Xavier DUVAL, MD
- Recruiting
CHU
Rennes
Fabrice LAINE, MD
- Recruiting
CHU
Saint-Etienne
Elisabeth BOTHELHO-NEVERS, MD
About this study
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.
Read the 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.
- Keywords
- Severe acute respiratory infection (SARI), Vaccine effectiveness, Influenza, COVID-19
- Medical subject headings
- Influenza, Human, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 48 hours
Secondary outcomes (5)
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
Measured: 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
Measured: up to 48 hours
Prevalence of viral and bacterial co-infections
Prevalence of other viruses and bacteria detected by PCR, antigen tests, microbiology samples.
Measured: up to 48 hours
Incidence of SARI by site
Incidence rate of SARI by sites
Measured: 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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start20 Jan 2023
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Respiratory Infection (SARI)Studies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- P95, I-REIVAC, EPICONCEPT, Institut de Recherche en Santé Publique, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582239
- Sponsor's protocol ID
- ANRS0285s
- Acronym
- RESPIVAC
- Status last verified
- May 2023
- First submitted
- 10 Oct 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults
- ClinicalTrials.gov ID
- NCT05582239
- Acronym / sponsor ID
- RESPIVAC / ANRS0285s
- Keywords
- Severe acute respiratory infection (SARI), Vaccine effectiveness, Influenza, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- P95, I-REIVAC, EPICONCEPT, Institut de Recherche en Santé Publique, France
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients presenting with SARI symptom onset in the first 14 days
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindication of vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaccine effectiveness
Time frame: 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.
5 secondary outcomes
Covid-19 vaccine effectiveness
Time frame: up to 48 hours
Influenza vaccine effectiveness
Time frame: up to 48 hours
Prevalence of viral and bacterial co-infections
Time frame: up to 48 hours
Incidence of SARI by site
Time frame: up to 12 months
Clinical burden of SARI
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Respiratory Infection (SARI) and Influenza, run by ANRS, Emerging Infectious Diseases at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Rekacewicz, MD (+ 33 1 42 34 83 75, claire.rekacewicz@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine effectiveness (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.