A Retrospective, Observational Registry of Participants With Avian Influenza Infection
Completed
- Conditions
- Influenza
- Registration Number
- NCT02743676
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This is a global, multi-center, observational registry of participants with suspected or confirmed infection with avian influenza A H5N1. Data are collected through retrospective abstraction, from detailed case reports that may be published and available in the public domain, or as incident cases received directly from the treating physician or other medical personnel.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 648
Inclusion Criteria
- Participants who develop influenza-like symptoms and who are considered to be epidemiologically linked by time, place, and exposure to a probable or confirmed avian influenza or human case of H5N1 infection are eligible for inclusion in the Registry. Cases with atypical symptom presentation (e.g., non-respiratory) are also included, in keeping with evolving knowledge about the clinical presentation of avian influenza.
- Participants with documented positive serological test who either remain asymptomatic or experience mild illness only
- Participants with laboratory confirmation of infection with influenza A (H5N1) who survive long enough to present for medical care
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Exclusion Criteria
- There are no exclusion criteria in this study
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with clinical outcome (death, recovery, or other overall clinical status) at the time of discharge from care Up to 5 years
- Secondary Outcome Measures
Name Time Method Number of Participants with at least One Adverse Event (AE) Up to 5 years