Influenza and Other Novel Respiratory VirusesNCT01056354
Respiratory Virus Outpatient Study (FLU 002 Plus)
An observational study of Influenza and Other Novel Respiratory Viruses, run by University of Minnesota at 68 sites in 15 countries.
Trial summary
Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza and Other Novel Respiratory Viruses
- How many people
- 11,719 participants
- Where
- 68 sitesin 15 countries
- Study dates
- Aug 2009to 12 May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons who seek medical care and are suspected of having influenza or a targeted novel respiratory virus* of major public health concern will be enrolled at numerous participating clinical sites on several continents. *The current list of other targeted novel respiratory viruses includes MERS-CoV and SARS-CoV.
Who may be able to join
- Be ≥ 18 years of age
- Have a signed informed consent by participant
- Have a fever (37.8 degrees C (100 degrees F) or higher on examination or patient-reported fever (37.8 degrees C (100 degrees F) or higher, or feverishness (felt febrile but did not take temperature) in the past 24 hours.
- Have a cough and/or sore throat
- Have suspected influenza or a suspected targeted non-influenza viral respiratory infection
Who cannot join
- Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness.
Trial locations and contacts
68 sites in 15 countries.
68 sites in 15 countries
United States17 sites
UNC AIDS Clinical Trials Unit
Chapel Hill, North Carolina, 27514
University of Tennessee College of Medicine
Chattanooga, Tennessee, 37403
University of Illinois at Chicago
Chicago, Illinois, 60612
Denver Public Health
Denver, Colorado, 80204
Henry Ford Health System
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
University of North Texas Health Science Center
Fort Worth, Texas, 76107
Houston AIDS Research Team
Houston, Texas, 77030
Cornell CRS
New York, New York, 10010
New Jersey Medical School Adult Clinical Research Center
Newark, New Jersey, 07103
Infectious Diseases Associates NW FL, PA
Pensacola, Florida, 32503
Virginia Commonwealth University
Richmond, Virginia, 23298
UCSD Antiviral Research Center
San Diego, California, 92103-8208
Newland Immunology Center of Excellence (NICE)
Southfield, Michigan, 48075
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
Argentina12 sites
CEMIC
Buenos Aires
FUNCEI
Buenos Aires
Hospital General de Agudos JM Ramos Mejia
Buenos Aires
Hospital Italiano de Buenos Aires
Buenos Aires
Hospital Privado Centro Medico de Cordoba
Córdoba
Hospital Rawson
Córdoba
Hospital Nacional Profesor Alejandro Posadas
El Palomar, Buenos Aires
Hospital Interzonal General de Agudos Dr. Diego Paroissien
La Matanza, Buenos Aires
Instituto Medico Platense
La Plata, Buenos Aires
CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral)
Rosario, Santa Fe Province
Sanatorio Britanico
Rosario, Santa Fe Province
Hospital Profesor Bernardo Houssay
Vicente López, Buenos Aires
Australia5 sites
Interchange General Practice
Canberra, Australian Capital Territory, 2601
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010
Northside Clinic
Fitzroy North, Victoria, 3068
Prahran Market Clinic
Melbourne, Victoria, 3181
Westmead Hospital
Westmead, New South Wales, 2145
Denmark4 sites
Arhus Universitetshospital, Skejby
Aarhus
CHIP
Copenhagen
Rigshospitalet, Infektionsmedicinsk ambulatorium 8622
Copenhagen
University Clinic of General Practice
Copenhagen
Germany4 sites
Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS
Bonn
Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV
Cologne
Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS
Frankfurt
Ifi - Studien und Projekte GmbH
Hamburg
Greece4 sites
1st Dept of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital
Athens
1st Respiratory Medicine Dept, Athens Hosp for Diseases of the Chest "Sotiria Hospital"
Athens
Evangelismos General Hospital
Athens
Hippokration University General Hospital of Athens
Athens
Peru4 sites
Hospital Nacional Arzobispo Loayza
Lima, 01
Asociacion Civil IMPACTA Salud y Educacion
Lima, 04
Hospital Nacional Edgardo Rebagliati Martins
Lima, 11
Hospital Nacional Guillermo Almenara Irigoyen
Lima, 13
United Kingdom4 sites
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, West Yorkshire, BD9 6RJ
Churchill Hospital
Headington, Oxford, OX3 9LJ
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
Chile3 sites
Clinica Alemana
Santiago
Fundacion Arriaran
Santiago
Pontificia Universidad Catolica de Chile
Santiago
Thailand3 sites
Chulalongkorn University Hospital
Bangkok, 10330
Khon Kaen University, Srinagarind Hospital
Khon Kaen, 40002
Bamrasnaradura Institute
Nonthaburi, 11000
Belgium2 sites
Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)
Brussels
Practimed Medisch Centrum Tessenderlo
Tessenderlo
Poland2 sites
Wojewodzki Szpital Zakazny
Warsaw
EMC Instytut Medyczny SA
Wroclaw
Spain2 sites
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Hospital Txagorritxu
Vitoria-Gasteiz
Japan1 site
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001
About this study
Official title: An International Observational Study to Characterize Adults With Influenza or Other Targeted Respiratory Viruses
Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded
Read the detailed description
The purpose of this observational study is to describe participants in geographically diverse locations with influenza virus infection and other viral respiratory diseases of public health importance and their clinical course over a 14-day period following enrollment.
Specific objectives related to influenza virus infection are to estimate the percentage of participants who go on to develop severe disease or complications that require hospitalization; to obtain information on risk factors for disease severity; and to establish a central repository of specimens for use in virus characterization, including subtyping, antigenic and genetic analyses, identification of signature mutations associated with antiviral drug resistance, mutational evolution, and additional reassortment.
Specific objectives related to novel non-influenza respiratory viruses of potential major public health importance are to characterize initial cases and their outcomes in order to develop more specific protocols that could inform the prevention and treatment of these new infections
Sample size is open-ended for this observational study. Based on experience to date, it is estimated that 75 sites will participate and will enroll approximately 1,700 patients with influenza each year, about one-half in the Northern Hemisphere and one-half in the Southern Hemisphere. Sites in diverse geographic locations on several continents will participate.
Study Plan:
- Participants who meet the eligibility criteria will be enrolled at participating clinical sites.
- At enrollment, consent is signed and information (demographics, medical history (including prior influenza and pneumococcal vaccination), medications (including antivirals) and treatments prescribed will be recorded. A blood sample for serum and plasma will be obtained at enrollment, as well as an upper respiratory tract specimen. The respiratory specimen will be sent for central reverse transcriptase polymerase chain reaction (RT-PCR) testing for influenza.
- Status will be re-assessed at approximately 14 days after enrollment and another blood sample for serum and plasma will be obtained. For participants with a confirmed novel respiratory virus of public health importance, attempts will be made to obtain a sample of the local specimen used to diagnose the infection.
In February 2012, the FLU 004 Genomics protocol v 1.0 was released to the field.
In August 2013 v 2.0 of the protocol was released as INSIGHT Genomics. The protocol was expanded beyond the FLU 002 and FLU 003 studies to include all qualifying INSIGHT studies (list posted on the INSIGHT website, www.insight-trials.org. The purpose of this substudy is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other genetic variants that may be associated with an increased risk of disease progression among individuals with infectious diseases of public health importance who are enrolled in qualifying INSIGHT studies.
Participating FLU 002 Plus sites are given the option to also participate in INSIGHT Genomics, which requires a separate protocol registration. Participants, once consented to FLU 002 Plus, will be offered the option to also consent to INSIGHT Genomics, which includes a single whole blood sample collection. Participation in FLU 002 Plus will not be compromised if a participant opts not to participate in INSIGHT Genomics.
- Keywords
- Influenza, respiratory virus, pandemic, swine flu, infection, MERS-CoV, SARS-CoV
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections, Infections, Severe Acute Respiratory Syndrome
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 |
|---|---|---|
| Influenza | Influenza A and subtypes such as H3N2 and 2009 H1N1 or influenza B | |
| Novel respiratory virus-1 | MERS-CoV (Middle Eastern Respiratory Syndrome Coronavirus) | |
| Novel respiratory virus-2 | SARS-CoV (Severe Acute Respiratory Syndrome Coronavirus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or Hospitalization
Death or hospitalization within 14 days of enrollment or the development of one severe complication.
Measured: 14-day period following enrollment
Secondary outcomes (1)
Days of work/school lost, duration of symptoms, use of antivirals
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startAug 2009
- Primary completion12 May 2017
- Study completion12 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Influenza and Other Novel Respiratory VirusesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,719 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- James Neaton, Professor, Principal investigator, University of Minnesota - Dept Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056354
- Sponsor's protocol ID
- 0603M83587 FLU 002
- Other IDs
- HHSN261200800001E ; 29XS214
- Status last verified
- Aug 2017
- First submitted
- 25 Jan 2010
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7.
PubMed 19423869World Health Organization (WHO), www.who.int/, accessed 26 August 2013
Guery B, Poissy J, el Mansouf L, Sejourne C, Ettahar N, Lemaire X, Vuotto F, Goffard A, Behillil S, Enouf V, Caro V, Mailles A, Che D, Manuguerra JC, Mathieu D, Fontanet A, van der Werf S; MERS-CoV study group. Clinical features and viral diagnosis of two cases of infection with Middle East Respiratory Syndrome coronavirus: a report of nosocomial transmission. Lancet. 2013 Jun 29;381(9885):2265-72. doi: 10.1016/S0140-6736(13)60982-4. Epub 2013 May 30.
PubMed 23727167Drosten C, Seilmaier M, Corman VM, Hartmann W, Scheible G, Sack S, Guggemos W, Kallies R, Muth D, Junglen S, Muller MA, Haas W, Guberina H, Rohnisch T, Schmid-Wendtner M, Aldabbagh S, Dittmer U, Gold H, Graf P, Bonin F, Rambaut A, Wendtner CM. Clinical features and virological analysis of a case of Middle East respiratory syndrome coronavirus infection. Lancet Infect Dis. 2013 Sep;13(9):745-51. doi: 10.1016/S1473-3099(13)70154-3. Epub 2013 Jun 17.
PubMed 23782859World Health Organization (WHO), Severe Acute Respiratory Syndrome (SARS), www.who.int/csr/sars/, accessed 26 August 2013
Simonsen L, Higgs E, Taylor RJ, Wentworth D, Cozzi-Lepri A, Pett S, Dwyer DE, Davey R, Lynfield R, Losso M, Morales K, Glesby MJ, Weckx J, Carey D, Lane C, Lundgren J; INSIGHT FLU002 and FLU003 Study Groups. Using Clinical Research Networks to Assess Severity of an Emerging Influenza Pandemic. Clin Infect Dis. 2018 Jul 18;67(3):341-349. doi: 10.1093/cid/ciy088.
PubMed 29746631Lynfield R, Davey R, Dwyer DE, Losso MH, Wentworth D, Cozzi-Lepri A, Herman-Lamin K, Cholewinska G, David D, Kuetter S, Ternesgen Z, Uyeki TM, Lane HC, Lundgren J, Neaton JD; INSIGHT Influenza Study Group. Outcomes of influenza A(H1N1)pdm09 virus infection: results from two international cohort studies. PLoS One. 2014 Jul 8;9(7):e101785. doi: 10.1371/journal.pone.0101785. eCollection 2014.
PubMed 25004134
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Observational Study to Characterize Adults With Influenza or Other Targeted Respiratory Viruses
- ClinicalTrials.gov ID
- NCT01056354
- Acronym / sponsor ID
- 0603M83587 FLU 002
- Keywords
- Influenza, respiratory virus, pandemic, swine flu, infection, MERS-CoV, SARS-CoV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,719 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
- Study start
- Aug 2009
- Primary completion
- 12 May 2017 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 26 Jan 2010 (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.
Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded
Detailed description
The purpose of this observational study is to describe participants in geographically diverse locations with influenza virus infection and other viral respiratory diseases of public health importance and their clinical course over a 14-day period following enrollment.
Specific objectives related to influenza virus infection are to estimate the percentage of participants who go on to develop severe disease or complications that require hospitalization; to obtain information on risk factors for disease severity; and to establish a central repository of specimens for use in virus characterization, including subtyping, antigenic and genetic analyses, identification of signature mutations associated with antiviral drug resistance, mutational evolution, and additional reassortment.
Specific objectives related to novel non-influenza respiratory viruses of potential major public health importance are to characterize initial cases and their outcomes in order to develop more specific protocols that could inform the prevention and treatment of these new infections
Sample size is open-ended for this observational study. Based on experience to date, it is estimated that 75 sites will participate and will enroll approximately 1,700 patients with influenza each year, about one-half in the Northern Hemisphere and one-half in the Southern Hemisphere. Sites in diverse geographic locations on several continents will participate.
Study Plan:
- Participants who meet the eligibility criteria will be enrolled at participating clinical sites.
- At enrollment, consent is signed and information (demographics, medical history (including prior influenza and pneumococcal vaccination), medications (including antivirals) and treatments prescribed will be recorded. A blood sample for serum and plasma will be obtained at enrollment, as well as an upper respiratory tract specimen. The respiratory specimen will be sent for central reverse transcriptase polymerase chain reaction (RT-PCR) testing for influenza.
- Status will be re-assessed at approximately 14 days after enrollment and another blood sample for serum and plasma will be obtained. For participants with a confirmed novel respiratory virus of public health importance, attempts will be made to obtain a sample of the local specimen used to diagnose the infection.
In February 2012, the FLU 004 Genomics protocol v 1.0 was released to the field.
In August 2013 v 2.0 of the protocol was released as INSIGHT Genomics. The protocol was expanded beyond the FLU 002 and FLU 003 studies to include all qualifying INSIGHT studies (list posted on the INSIGHT website, www.insight-trials.org. The purpose of this substudy is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other genetic variants that may be associated with an increased risk of disease progression among individuals with infectious diseases of public health importance who are enrolled in qualifying INSIGHT studies.
Participating FLU 002 Plus sites are given the option to also participate in INSIGHT Genomics, which requires a separate protocol registration. Participants, once consented to FLU 002 Plus, will be offered the option to also consent to INSIGHT Genomics, which includes a single whole blood sample collection. Participation in FLU 002 Plus will not be compromised if a participant opts not to participate in INSIGHT Genomics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Influenza | – | –Influenza A and subtypes such as H3N2 and 2009 H1N1 or influenza B |
| Novel respiratory virus-1 | – | –MERS-CoV (Middle Eastern Respiratory Syndrome Coronavirus) |
| Novel respiratory virus-2 | – | –SARS-CoV (Severe Acute Respiratory Syndrome Coronavirus) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons who seek medical care and are suspected of having influenza or a targeted novel respiratory virus* of major public health concern will be enrolled at numerous participating clinical sites on several continents. *The current list of other targeted novel respiratory viruses includes MERS-CoV and SARS-CoV.
Key inclusion criteria (5 listed)
- Be ≥ 18 years of age
- Have a signed informed consent by participant
- Have a fever (37.8 degrees C (100 degrees F) or higher on examination or patient-reported fever (37.8 degrees C (100 degrees F) or higher, or feverishness (felt febrile but did not take temperature) in the past 24 hours.
- Have a cough and/or sore throat
- Have suspected influenza or a suspected targeted non-influenza viral respiratory infection
Key exclusion criteria (1 listed)
- Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness.
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
Death or Hospitalization
Time frame: 14-day period following enrollment
Death or hospitalization within 14 days of enrollment or the development of one severe complication.
1 secondary outcome
Days of work/school lost, duration of symptoms, use of antivirals
Time frame: 14 days
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 18 Aug 2017.
- Background: PubMed 19423869Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7.
- BackgroundWorld Health Organization (WHO), www.who.int/, accessed 26 August 2013
- Background: PubMed 23727167Guery B, Poissy J, el Mansouf L, Sejourne C, Ettahar N, Lemaire X, Vuotto F, Goffard A, Behillil S, Enouf V, Caro V, Mailles A, Che D, Manuguerra JC, Mathieu D, Fontanet A, van der Werf S; MERS-CoV study group. Clinical features and viral diagnosis of two cases of infection with Middle East Respiratory Syndrome coronavirus: a report of nosocomial transmission. Lancet. 2013 Jun 29;381(9885):2265-72. doi: 10.1016/S0140-6736(13)60982-4. Epub 2013 May 30.
- Background: PubMed 23782859Drosten C, Seilmaier M, Corman VM, Hartmann W, Scheible G, Sack S, Guggemos W, Kallies R, Muth D, Junglen S, Muller MA, Haas W, Guberina H, Rohnisch T, Schmid-Wendtner M, Aldabbagh S, Dittmer U, Gold H, Graf P, Bonin F, Rambaut A, Wendtner CM. Clinical features and virological analysis of a case of Middle East respiratory syndrome coronavirus infection. Lancet Infect Dis. 2013 Sep;13(9):745-51. doi: 10.1016/S1473-3099(13)70154-3. Epub 2013 Jun 17.
- BackgroundWorld Health Organization (WHO), Severe Acute Respiratory Syndrome (SARS), www.who.int/csr/sars/, accessed 26 August 2013
- Derived from this study: PubMed 29746631Simonsen L, Higgs E, Taylor RJ, Wentworth D, Cozzi-Lepri A, Pett S, Dwyer DE, Davey R, Lynfield R, Losso M, Morales K, Glesby MJ, Weckx J, Carey D, Lane C, Lundgren J; INSIGHT FLU002 and FLU003 Study Groups. Using Clinical Research Networks to Assess Severity of an Emerging Influenza Pandemic. Clin Infect Dis. 2018 Jul 18;67(3):341-349. doi: 10.1093/cid/ciy088.
- Derived from this study: PubMed 25004134Lynfield R, Davey R, Dwyer DE, Losso MH, Wentworth D, Cozzi-Lepri A, Herman-Lamin K, Cholewinska G, David D, Kuetter S, Ternesgen Z, Uyeki TM, Lane HC, Lundgren J, Neaton JD; INSIGHT Influenza Study Group. Outcomes of influenza A(H1N1)pdm09 virus infection: results from two international cohort studies. PLoS One. 2014 Jul 8;9(7):e101785. doi: 10.1371/journal.pone.0101785. eCollection 2014.
- INSIGHT websiteLink 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.
James Neaton, Professor principal investigator
University of Minnesota - Dept Biostatistics
68 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Other Novel Respiratory Viruses, run by University of Minnesota at 68 sites in 15 countries.
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 5 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 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, Argentina, Australia, Denmark, Germany and 10 more countries. 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?
Death or Hospitalization (time frame: 14-day period following enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056354, which also lists 7 linked publications.
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 18 Aug 2017.