A/H1N1 InfluenzaNCT01298206
Case-control Study of Pandemic A/H1N1 Influenza Risk Factors In Lebanon
An observational study of A/H1N1 Influenza and Swine Flu, run by St. Jude Children's Research Hospital at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- A/H1N1 Influenza, Swine Flu
- Type of treatment
- Vaccines
- How many people
- 129 participants
- Where
- 1 siteLebanon
- Study dates
- Oct 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Conditions
- A/H1N1 Influenza, Swine Flu
- Keywords
- A/H1N1 Influenza, swine flu, virus disease, Avian flu
- Medical subject headings
- Orthomyxoviridae Infections, Virus Diseases, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One (1) year
Secondary outcomes (2)
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.
Measured: One (1) year
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).
Measured: One (1) year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A/H1N1 InfluenzaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American University of Beirut Medical Center
- Responsible party
- Sponsor
- Investigators
- Ghazi Kayali, Ph.D, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298206
- Sponsor's protocol ID
- XPD10-150 PANFLU
- Other IDs
- CDRF-BEP-22033
- Status last verified
- Nov 2013
- First submitted
- 15 Feb 2011
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-control Study of Pandemic A/H1N1 Influenza Risk Factors In Lebanon
- ClinicalTrials.gov ID
- NCT01298206
- Acronym / sponsor ID
- XPD10-150 PANFLU
- Conditions
- A/H1N1 Influenza, Swine Flu
- Keywords
- A/H1N1 Influenza, swine flu, virus disease, Avian flu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- American University of Beirut Medical Center
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
This study will characterize influenza viruses causing infection by using molecular and cultural techniques
Time frame: One (1) year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
- St. Jude Children's Research HospitalLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghazi Kayali, Ph.D, MPH principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of A/H1N1 Influenza and Swine Flu, run by St. Jude Children's Research Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.