Avian Influenza Studies In Lebanon

Completed

• Conditions: Avian Influenza; Virus Diseases

• Registration Number: NCT01107262
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

The highly pathogenic avian influenza (HPAI) H5N1 virus arrived in the Middle East in 2005 and has since established itself in local domestic birds and is now considered endemic in several Middle Eastern countries.Few studies indicate the presence of low pathogenicity avian influenza (LPAI) viruses of the H9 type among Lebanese poultry and wild birds. These studies also provide some evidence suggesting that humans exposed to these sick birds are showing elevated antibody titers against these LPAI H9 viruses.

This study will focus on the following objectives:

* To determine the seroprevalence of AI in poultry-exposed and non-exposed human populations.

* To identify risk factors associated with AI infections in occupationally-exposed poultry workers.

* To conduct nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks.

Detailed Description

This study will examine the sera of 200 poultry-exposed adults and 50 adult controls and administer questionnaires to identify risk factors for AI infections in human beings.Study volunteers will be interviewed regarding their exposures, medical history, and behaviors using a close-ended questionnaire specifically tailored for this study. A blood sample will be collected from every participant to verify presence of antibodies against the viruses under study. All study materials are in English and Arabic. Along side the human aspect of the study, specimens will be collected from the birds that the individual handles.

This study hypothesizes that they will find evidence of previous infection with these viruses among poultry workers. Furthermore, the study team will collect animal specimens from the farms of the study volunteers and determine the types of Avian Influenza viruses that they harbour.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-26
• Last Update Posted: 2011-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Be at least 18 years old.
• Be willing to participate by signing a consent form, completing the study questionnaire, and providing a blood sample.

Exclusion Criteria

• Less than 18 years old.
• Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy. (Note that we have chosen to exclude such populations because of their increased risk of acquiring infections, they are relatively few, and are not representative of a national sample).
• Any individual with unknown poultry exposure status, or who was exposed to poultry more than 5 years ago.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The seroprevalence of Avian Influenza in poultry-exposed and non-exposed human populations.	1 year
Risk factors associated with AI infections in occupationally-exposed poultry workers.	1 year
Nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks.	1 year

Trial Locations

Locations (2)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

American University of Beirut; 🇱🇧 Beirut, Lebanon