A Retrospective, Observational Registry of Participants With Avian Influenza Infection

April 15, 2016 updated by: Hoffmann-La Roche

Avian/Pandemic Influenza Registry

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

648

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Retrospective data are collected from participants with suspected or confirmed infection with avian influenza A H5N1.

Description

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

Exclusion Criteria:

- There are no exclusion criteria in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with clinical outcome (death, recovery, or other overall clinical status) at the time of discharge from care
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with at least One Adverse Event (AE)
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV22158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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