Measuring how well vaccines prevent hospitalizations for viral respiratory infections in adults
Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults
This study is testing how well vaccines can keep adults from being hospitalized due to serious respiratory infections like the flu and COVID-19.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ANRS, Emerging Infectious Diseases Government |
| Locations | 8 sites (Dijon and 7 other locations) |
| Trial ID | NCT05582239 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of vaccines in preventing hospitalizations due to Severe Acute Respiratory Infections (SARI), including influenza and COVID-19, in adults. Patients aged 18 and older who are hospitalized for at least 24 hours and meet specific clinical criteria will be invited to participate. Data on socio-demographics, clinical status, and virological results will be collected through electronic forms. Follow-up evaluations will occur at 1 and 3 months post-discharge to monitor health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are hospitalized with symptoms of Severe Acute Respiratory Infection.
Not a fit: Patients with contraindications to vaccination may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of vaccines in reducing severe cases of respiratory infections, potentially guiding public health policies.
How similar studies have performed: Other studies have shown promising results in assessing vaccine effectiveness against respiratory infections, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dijon and 7 other locations
- Chu — Dijon, France (Recruiting)
- Groupement hospitalier Edouard Herriot — Lyon, France (Recruiting)
- Hôpital Gui de Chauliac — Montpellier, France (Recruiting)
- Chu — Nantes, France (Recruiting)
- Hôpital Cochin — Paris, France (Recruiting)
- Hôpital Bichat — Paris, France (Recruiting)
- Chu — Rennes, France (Recruiting)
- Chu — Saint-Étienne, France (Recruiting)
Study contacts
- Study coordinator: Claire Rekacewicz, MD
- Email: claire.rekacewicz@inserm.fr
- Phone: + 33 1 42 34 83 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.