Avian InfluenzaNCT01107262
Avian Influenza Studies In Lebanon
An observational study of Avian Influenza and Virus Diseases, run by St. Jude Children's Research Hospital at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Avian Influenza, Virus Diseases
- How many people
- 250 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Be at least 18 years old.
- Be willing to participate by signing a consent form, completing the study questionnaire, and providing a blood sample.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Avian Influenza, Virus Diseases
- Keywords
- H5N1 Subtype, Avian viruses, Highly pathogenic avian influenza (HPAI)
- Medical subject headings
- Influenza in Birds, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroprevalence of Avian Influenza in poultry-exposed and non-exposed human populations.
Measured: 1 year
Risk factors associated with AI infections in occupationally-exposed poultry workers.
Measured: 1 year
Nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avian InfluenzaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American University of Beirut Medical Center
- Responsible party
- Sponsor
- Investigators
- Mohammad Ghazi Kayali, Ph.D, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107262
- Sponsor's protocol ID
- AVIFLU -XPD09-010
- Status last verified
- Oct 2011
- First submitted
- 19 Apr 2010
- Last updated
- 27 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avian Influenza Studies In Lebanon
- ClinicalTrials.gov ID
- NCT01107262
- Acronym / sponsor ID
- AVIFLU -XPD09-010
- Conditions
- Avian Influenza, Virus Diseases
- Keywords
- H5N1 Subtype, Avian viruses, Highly pathogenic avian influenza (HPAI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- American University of Beirut Medical Center
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Be at least 18 years old.
- Be willing to participate by signing a consent form, completing the study questionnaire, and providing a blood sample.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The seroprevalence of Avian Influenza in poultry-exposed and non-exposed human populations.
Time frame: 1 year
Risk factors associated with AI infections in occupationally-exposed poultry workers.
Time frame: 1 year
Nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2011.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Ghazi Kayali, Ph.D, MPH principal investigator
St. Jude Children's Research Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Avian Influenza and Virus Diseases, run by St. Jude Children's Research Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The seroprevalence of Avian Influenza in poultry-exposed and non-exposed human populations. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2011.