Sentinel surveillance for influenza requiring hospital admission in Canadian adults
Trial overview
Occurrence of any polymerase chain reaction (PCR)-confirmed influenza virus infection in vaccinated (>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 65 years of age.
Timeframe: Within 7 days of admission to hospital.
Burden of disease, clinical outcomes and resource utilization in subjects associated with influenza A and influenza B lineages.
Timeframe: Between admission and 30 days post discharge from hospital.
Occurrence of death attributed to influenza in patients < 65 years.
Timeframe: Between admission and 30 days post discharge from hospital.
Clinical risk factors impacting on severity of disease: baseline Frailty Index and Frail Scale, age, gender, underlying medical comorbidities, immunization status, smoking, obesity, pregnancy, and ethnicity.
Timeframe: At baseline upon admission and again within 30 Days post-discharge from hospital.
Severity of the disease: need for admission to an intensive care unit, need for mechanical ventilation, length of stay, and complications.
Timeframe: At baseline upon admission and again within 30 days post discharge from hospital.
Occurrence of any PCR-confirmed influenza virus infection in vaccinated (>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 16 years of age.
Timeframe: Within 7 days of admission to hospital.
Occurrence of death attributed to influenza in patients ≥ 65 years.
Timeframe: Between admission and 30 days post discharge from hospital.
Participation criteria
- Adult patients ≥ 16 years of age admitted to participating SOS Network hospitals with the following:
- Pneumonia;
- Patients whose reason for admission was clearly unrelated to the presence of influenza (for example, patients admitted due to trauma, elective surgery, or patients who have an alternative diagnosis that is clearly not respiratory, e.g. cellulitis, intra-abdominal process, or gastrointestinal bleeding) unless being enrolled as a nosocomial influenza case.
- Patients whose onset of symptoms was prior to or within 72 hours of hospital admission but who were not tested for influenza within 7 days of hospital admission. These should be captured on the screening form as screen failures.
- Pneumonia;
- Acute exacerbation of chronic obstructive pulmonary disease (AE COPD) or asthma;
- Unexplained sepsis;
- Any other respiratory infection or diagnosis;
- Laboratory-confirmed nosocomial influenza during current hospital admission.
Adult patients ≥ 16 years of age admitted to participating SOS Network hospitals with the following:
Any respiratory or influenza-like symptom (e.g. dyspnea, cough, sore throat, myalgia, arthralgia, fever, delirium/altered level of consciousness, congestive heart failure).
- Patients whose onset of symptoms was prior to or within 72 hours of hospital admission but who were not tested for influenza within 7 days of hospital admission. These should be captured on the screening form as screen failures.
- Children in care.
Patients whose reason for admission was clearly unrelated to the presence of influenza (for example, patients admitted due to trauma, elective surgery, or patients who have an alternative diagnosis that is clearly not respiratory, e.g. cellulitis, intra-abdominal process, or gastrointestinal bleeding) unless being enrolled as a nosocomial influenza case.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.