An observational study in Severe Acute Respiratory Infection (SARI), Influenza and COVID-19, sponsored by ANRS, Emerging Infectious Diseases. Status unknown at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by ANRS, Emerging Infectious Diseases · Observational
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.
2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 300 across 313 observational studies indexed under Influenza, Human.
Browse Influenza, Human studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hospitalized patients presenting with SARI symptom onset in the first 14 days
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
Exclusion Criteria:
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Jan 2026, 36 months after the start.
Of 86 non-industry observational studies under Influenza, Human, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 92. This study's planned 36 months is above that.
Counting every sponsor, half of 121 studies reached it within 20 months; a quarter within 7 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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ANRS, Emerging Infectious Diseases →