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

NCT01298206 | Completed

• 2 other identifiers: XPD10-150 PANFLUCDRF-BEP-22033
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

A/H1N1 Influenza; Swine Flu

Keywords

A/H1N1 Influenza; swine flu; virus disease; Avian flu

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• This study will characterize influenza viruses causing infection by using molecular and cultural techniques

  One (1) year

• This study will investigate the risk factors of severe illness or death associated with infection with the pandemic A/H1N1 viruses.

  One (1) year

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• American University of Beirut Medical Center: collaborator

Study Sites (1)

American University of Beirut

Beirut, Beyrouth, 1107-2020, Lebanon

Location

Related Links

• St. Jude Children's Research Hospital

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.

MeSH Terms

Conditions

Orthomyxoviridae Infections; Virus Diseases; Influenza in Birds

Condition Hierarchy (Ancestors)

RNA Virus Infections; Infections; Bird Diseases; Animal Diseases

Study Officials

• Ghazi Kayali, Ph.D, MPH

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 17, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

LE (1)