Avian Influenza Studies In Lebanon
| Tracking Information | |||||
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| First Received Date ICMJE | April 19, 2010 | ||||
| Last Updated Date | October 26, 2011 | ||||
| Start Date ICMJE | July 2009 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01107262 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Avian Influenza Studies In Lebanon | ||||
| Official Title ICMJE | Avian Influenza Studies In Lebanon | ||||
| 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:
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: 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. |
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| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 250 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Lebanon | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01107262 | ||||
| Other Study ID Numbers ICMJE | AVIFLU -XPD09-010 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | St. Jude Children's Research Hospital | ||||
| Study Sponsor ICMJE | St. Jude Children's Research Hospital | ||||
| Collaborators ICMJE | American University of Beirut Medical Center | ||||
| Investigators ICMJE |
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| Information Provided By | St. Jude Children's Research Hospital | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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