Clinical trial NCT01107262: Avian Influenza Studies In Lebanon
Official title: Avian Influenza Studies In Lebanon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Avian Influenza
Virus Diseases
Keywords: H5N1 Subtype
Avian viruses
Highly pathogenic avian influenza (HPAI)
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: American University of Beirut Medical Center
First posted: 2010-04-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted in the rural areas of Lebanon where poultry production is located.Specifically, three main regions will be included in this study, the Beqaa, North Lebanon, and South Lebanon regions.The Mount Lebanon and Beirut regions are heavily urbanized and poultry production in these regions is minimal.Poultry-exposed individuals will be enrolled according to the following scheme:100 from Beqaa, 50 from North Lebanon, and 50 from South Lebanon. The 50 non-exposed individuals will be enrolled from Beirut.

Villages will be randomly selected from each of the 3 regions where enrollment will occur.Each village will be assigned a number and then a random digit sheet will be generated and used to randomly select villages.

Controls, adults who were never exposed to poultry, will be enrolled from urban areas such as the capital Beirut. Controls will be invited to volunteer by word of mouth at public/community sites.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The seroprevalence of Avian Influenza in poultry-exposed and non-exposed human populations.
timeFrame: 1 year
measure: Risk factors associated with AI infections in occupationally-exposed poultry workers.
timeFrame: 1 year
measure: Nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Mohammad Ghazi Kayali, Ph.D, MPH
role: PRINCIPAL_INVESTIGATOR
References: