Case-control Study of Pandemic A/H1N1 Influenza Risk Factors In Lebanon

Swine Flu Clinical Trial

Official title:

Case-control Study of Pandemic A/H1N1 Influenza Risk Factors In Lebanon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298206
• Other study ID #: XPD10-150 PANFLU
• Secondary ID: CDRF-BEP-22033
• Status: Completed
• Phase: N/A
• First received: February 15, 2011
• Last updated: November 20, 2013
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2013
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years and older

Eligibility

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).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• A/H1N1 Influenza
• Influenza, Human
• Swine Flu

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This study will investigate the risk factors with pandemic A/H1N1 virus by measuring the degree of exposure to virus;	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.	One (1) year	No
Secondary	This study will characterize influenza viruses causing infection by using molecular and cultural techniques	Through these techniques, the study will isolate and characterize influenza viruses causing infection and morbidity severity of infection among the enrolled cases.	One (1) year	No
Secondary	This study will investigate the risk factors of severe illness or death associated with infection with the pandemic A/H1N1 viruses.	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).	One (1) year	No

External Links

•   St. Jude Children's Research Hospital