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NCT02743676 Clinical Trial

A Retrospective, Observational Registry of Participants With Avian Influenza Infection

Influenza Clinical Trial

Official title:
Avian/Pandemic Influenza Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02743676
Other study ID # NV22158
Secondary ID
Status Completed
Phase N/A
First received April 15, 2016
Last updated April 15, 2016
Start date January 2007
Est. completion date March 2012

Study information
Verified date April 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 648
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 120 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with clinical outcome (death, recovery, or other overall clinical status) at the time of discharge from care Up to 5 years No
Secondary Number of Participants with at least One Adverse Event (AE) Up to 5 years No
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