Case-control Study of Pandemic A/H1N1 Influenza Risk Factors In Lebanon
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|ClinicalTrials.gov Identifier: NCT01298206|
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : November 21, 2013
|Condition or disease|
|A/H1N1 Influenza Swine Flu|
This study will measure risk and protective factors associated with pandemic A/H1N1 infection. This study will also be able to estimate risk factors for severe illness requiring hospitalization or leading to death. These factors are: travel history, exposure to other confirmed or suspected cases, obesity, pregnancy, influenza vaccination history, residency in nursing homes, attendance of daycares, tobacco use, and other comorbidities (pulmonary diseases, cardiovascular diseases, diabetes, renal insufficiency). Unlike other descriptive studies, this analytical case-control study will enable to accurately measure the strength of association between potential risk factors and outcome. By isolating viruses from specimens collected from cases, this study will be able to characterize these viruses and document any genetic mutations or antiviral resistance.
The main objectives of this study are:
- To investigate the risk factors of infection with the pandemic A/H1N1 viruses.
- To characterize influenza viruses causing infection.
- If enough severe cases were enrolled to make it statistically feasible, this study will investigate the risk factors of severe illness or death associated with infection with the pandemic A/H1N1 viruses.
|Study Type :||Observational|
|Actual Enrollment :||129 participants|
|Observational Model:||Case Control|
|Official Title:||Case-control Study of Pandemic A/H1N1 Influenza Risk Factors In Lebanon|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
H1N1 not exposed controls
For every enrolled H1N1 case, the study will enroll 2 sex matched controls. On the date of enrollment of a case, 2 sex-matched controls will be located from the same clinic from which the case was enrolled. Enrolled controls will then be verified to be free from influenza infection at the time of enrollment by RT-PCR.
H1N1 exposed Cases
A swab will be collected from cases to verify presence of pandemic influenza. Testing positive for influenza A/H1N1 by RT PCR to be enrolled will be confirmed as a case. The participant will be presented with a questionnaire that will capture exposure data through a group of variables assessing underlying health conditions, symptoms, use of influenza vaccine, travel, occupational setting, and other demographic variables. Cases will be contacted once during the study.
- This study will investigate the risk factors with pandemic A/H1N1 virus by measuring the degree of exposure to virus; [ Time Frame: One (1) year ]This study hypothesize that certain factors make people more vulnerable to be infected with A/H1N1, such as traveling to H1N1 infected area, exposure to infected patients, no influenza vaccination, residency in nursing homes, attendance of daycares, poor health and etc.
- This study will characterize influenza viruses causing infection by using molecular and cultural techniques [ Time Frame: One (1) year ]Through these techniques, the study will isolate and characterize influenza viruses causing infection and morbidity severity of infection among the enrolled cases.
- This study will investigate the risk factors of severe illness or death associated with infection with the pandemic A/H1N1 viruses. [ Time Frame: One (1) year ]This study hypothesizes that certain factors make patients infected with A/H1N1 more vulnerable to severe illness or death, such as obesity, pregnancy, tobacco use, and other co-morbidities (pulmonary diseases, cardiovascular diseases, diabetes, and renal insufficiency).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298206
|American University of Beirut|
|Beirut, Lebanon, 1107-2020|
|Principal Investigator:||Ghazi Kayali, Ph.D, MPH||St. Jude Children's Research Hospital|