Surveillance of Respiratory Pathogens and Brand-Specific Vaccine Effectiveness in Adults Hospitalised with SARI: An Observational Study (former id.DRIVE surveillance study of respiratory pathogens in adults hospitalised for severe acute respiratory infection (SARI) across Europe)

Study type

• Study topic:
  Disease /health condition
• Study topic, other:
  Surveillance of respiratory pathogens + vaccine effectiveness (COVID-19 and RSV)
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Feasibility analysis
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Test-negative case control

Study drug and medical condition

• Medical condition to be studied:
  Severe acute respiratory syndrome
• Additional medical condition(s):
  Severe Acute Respiratory Infection (SARI)

Population studied

• Short description of the study population:
  Adults aged 18 years and older (patients), presenting at the participating hospitals during the study period, who are willing and able to provide informed consent (or alternatively, informed consent is obtained form the patient´s legally acceptable representatitve) AND who are hospitalised and meet the SARI patient definition. ; ; A SARI patient is defined as a hospitalised person with a suspicion of a respiratory infection with at least one of the following symptoms:; • new or worsening cough; • fever (≥ 38 C°); • new or worsening shortness of breath; • sudden onset of anosmia, ageusia or dysgeusia; with symptom onset within the last 14 days prior to hospital admission.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  Non-interventional multi-country, multi-centre, hospital-based surveillance and vaccine effectiveness study.
• Main study objective:
  Surveillance module:; This surveillance study aims to establish active surveillance for hospitalised SARI cases in adults in Europe. ; Primary objectives:; 1. To calculate the proportion of laboratory samples positive for each viral respiratory pathogen of interest among adult patients hospitalised with SARI; 2. To characterise adult SARI patients (including age, gender, protective and risk factors, specific treatments, and healthcare utilisation outcomes) overall and by viral respiratory pathogen of interest; ; CVE module (paused):; Primary objective:; To estimate brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 in SARI patients who have received the COVID-19 vaccine dose of interest, compared to the selected comparator group; ; RSV VE module:; Primary objective:; To estimate RSV VE for brand-specific RSV vaccine against hospitalisation due to laboratory-confirmed RSV infection overall or within a specific timeframe from vaccination in adult patients with SARI, eligible to receive the vaccine
• Setting:
  Hospitals
• Outcomes:
  Surveillance module (Sep 2024-ongoing):; The outcome of interest for the primary objectives will be laboratory-confirmed infection with one of the viral respiratory pathogens of interest in patients hospitalised with SARI symptoms, and laboratory-confirmed co-infection for the secondary objectives (prevalence of co-infection with the viral respiratory pathogens of interest, in adult patients hospitalised with SARI, and the impact on healthcare utilisation outcomes [level of severity, hospital discharge destination, length of hospital stay]). ; Pathogen-specific SARI incidences will be calculated to address the first exploratory objective (pathogen-specific SARI incidences and description of trends in hospitalised adults [time period, country, level of severity]). ; The denominator will be based on the sum of the catchment populations covered by the Study Contributors. ; For the second exploratory objective, feasibility assessments for future respiratory disease impact and effectiveness studies will be made. ; ; CVE module (Sep 2021-Aug 2026; currently paused):; The primary endpoint is hospitalisation due to laboratory-confirmed SARS-CoV-2 infection in adult patients with SARI.; Genomic sequencing is an optional component of the study. Sites opting into this module will perform sequencing using commercially available molecular kits. For prospective data collection, participating sites aim to sequence all SARS‑CoV‑2–positive cases. For retrospective data, sequencing results will be used if present in medical records.; ; RSV VE module (Sep 2024-ongoing):; The primary endpoint is hospitalisation due to laboratory-confirmed RSV infection in adult patients with SARI who were eligible for vaccination in their country.; The secondary endpoints in patients hospitalised with SARI symptoms include the detection of RSV subtypes A and B.; Information on the RSV subtypes (A and B) will be collected to the extent possible, preferably on all confirmed RSV cases when sample quality allows.
• Data analysis plan:
  A statistical analysis plan (SAP) is developed prior to the conduct of the analysis. The SAP specifies all statistical analyses, including sensitivity analyses, to be conducted and includes table shells and mock figures.