Avian Influenza Studies In Lebanon

This study has been completed.
Sponsor:
Collaborator:
American University of Beirut Medical Center
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01107262
First received: April 19, 2010
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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.

Condition
Avian Influenza
Virus Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Avian Influenza Studies In Lebanon

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • The seroprevalence of Avian Influenza in poultry-exposed and non-exposed human populations. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Risk factors associated with AI infections in occupationally-exposed poultry workers. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

A trained phlebotomist will collect a tube of blood (7.5ml) in serum separator tubes. The blood will be allowed to clot at room temperature then centrifuged on the same day. Serum specimens will be aliqouted into multiple cryovials, labelled and preserved at -20°C until ready for laboratory study.


Enrollment: 250
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Poultry exposed adults
This seroepidemiological study proposes to compare adults with occupational exposure to poultry with non-poultry exposed adult controls for evidence of previous infections with AI viruses.In this study, any person with occupational exposure to poultry i.e. works in poultry production facility or raises a smaller number of poultry on his/her farm will be considered exposed. The questionnaire used in this study will capture poultry exposure data through a group of variables assessing type of occupational setting, length of time of exposure, flock size, type of work performed, and personal protective equipment (PPE) used.
Poultry Non-exposed Adult Controls
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107262

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Lebanon
American University of Beirut
Beirut, Lebanon, 1107-2020
Sponsors and Collaborators
St. Jude Children's Research Hospital
American University of Beirut Medical Center
Investigators
Principal Investigator: Mohammad Ghazi Kayali, Ph.D, MPH St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01107262     History of Changes
Other Study ID Numbers: AVIFLU -XPD09-010
Study First Received: April 19, 2010
Last Updated: October 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
H5N1 Subtype
Avian viruses
Highly pathogenic avian influenza (HPAI)

Additional relevant MeSH terms:
Influenza in Birds
Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014