Avian Influenza Studies In Lebanon

Virus Diseases Clinical Trial

Official title:

Avian Influenza Studies In Lebanon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107262
• Other study ID #: AVIFLU -XPD09-010
• Status: Completed
• Phase: N/A
• First received: April 19, 2010
• Last updated: October 26, 2011
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2011
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Avian Influenza
• Influenza, Human
• Virus Diseases

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	American University of Beirut Medical Center

Countries where clinical trial is conducted

United States,  Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The seroprevalence of Avian Influenza in poultry-exposed and non-exposed human populations.		1 year	No
Primary	Risk factors associated with AI infections in occupationally-exposed poultry workers.		1 year	No
Primary	Nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks.		1 year	No

External Links

•   St. Jude Children's Research Hospital