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

This study has been completed.
Sponsor:
Collaborator:
American University of Beirut Medical Center
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01298206
First received: February 15, 2011
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition
A/H1N1 Influenza
Swine Flu

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Case-control Study of Pandemic A/H1N1 Influenza Risk Factors In Lebanon

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • This study will characterize influenza viruses causing infection by using molecular and cultural techniques [ Time Frame: One (1) year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Specimens collected from cases(ie positive for pandemic influenza by RT PCR) will be processed in order to isolate and characterize the viruses causing infection.


Enrollment: 129
Study Start Date: October 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed 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.
  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Cases will be selected from the outpatient clinics and inpatient units at American Univeristy of Beirut thus the study team expect that selection bias would be minimal. Confirmed cases attending other healthcare facilities for whom contact information is available, will be contacted and invited to participate in this study. Controls will be selected from the outpatient clinics and inpatient units of the Internal Medicine, Family Medicine, and Pediatric and Adolescent Medicine Departments at AUBMC. Cases and controls attending the hospital will be from the same catchment area, thus coming from the same geographical areas, have similar socioeconomic status, and have similar chances of exposure to influenza viruses. Other influenza case control studies have matched on sex and enrolled hospital-based controls.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298206

Locations
Lebanon
American University of Beirut
Beirut, Lebanon, 1107-2020
Sponsors and Collaborators
St. Jude Children's Research Hospital
American University of Beirut Medical Center
Investigators
Principal Investigator: Ghazi Kayali, Ph.D, MPH St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01298206     History of Changes
Other Study ID Numbers: XPD10-150 PANFLU, CDRF-BEP-22033
Study First Received: February 15, 2011
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
A/H1N1 Influenza
swine flu
virus disease
Avian flu

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014