A Retrospective, Observational Registry of Participants With Avian Influenza Infection

NCT ID: NCT02743676

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

648 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-03-31

Brief Summary

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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

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Conditions

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Influenza

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Avian influenza A

Natural history of Avian influenza A, particularly H5N1 strain which has a high potential of causing a global human pandemic, and real-world treatment practices will be observed in this study. This registry program will not require, recommend, or provide any specific treatment or medications.

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Other Identifiers

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NV22158

Identifier Type: -

Identifier Source: org_study_id

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