Case-control Study of Pandemic A/H1N1 Influenza Risk Factors In Lebanon
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | October 2011 |
| End Date: | August 2012 |
| Contact: | Ghazi Kayali, Ph.D, MPH |
| Email: | info@stjude.org |
| Phone: | 1-866-278-5833 |
The pandemic A/H1N1 virus was named "swine flu" when the current outbreak started. Although
it is not yet confirmed that the index case acquired the virus from pigs, the nomenclature
"swine flu" was due to the fact that the virus is triple-reassortant with genes from swine,
avian, and human influenza origins. A total of 57,809 cases were reported in the WHO EMRO
region, 693 of whom have died (1.2% case fatality). Lebanon had 1,838 confirmed cases with 5
deaths, it is estimated that 4% of these cases required hospitalization. Most cases of
pandemic influenza presented with fever, cough, and sore throat. Other common symptoms
included myalgia, headache, and rhinorrhea. The pandemic A/H1N1 virus appears to be very
successful at human-to-human transmission. It is also causing infections beyond the
traditional seasonal variation of previous human influenza viruses. Unlike seasonal
influenza viruses that usually cause severe infections requiring hospitalization among the
elderly and children under 5 years old, the pandemic A/H1N1 viruses are causing more severe
illness among young adults. Several reports have associated certain underlying conditions
with severe illness. Such conditions were pregnancy, asthma, diabetes, obesity, and heart
disease
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:
1. To investigate the risk factors of infection with the pandemic A/H1N1 viruses.
2. To characterize influenza viruses causing infection.
3. 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.
Inclusion Criteria:
- Be willing to participate by signing a consent form/assent statement, and completing
the study requirements.
- Be willing to provide nasal swab.
- Testing negative for influenza A/H1N1 by RT PCR to be enrolled as a control.
- Testing positive for influenza A/H1N1 by RT PCR to be enrolled as a case.
Exclusion Criteria:
*Any known immunosuppressive condition or immune deficiency disease (including HIV
infection), or ongoing receipt of any immunosuppressive therapy. (Note that this study has
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).
We found this trial at
1
site
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
Click here to add this to my saved trials
