Influenza and Other Novel Respiratory Viruses Clinical Trial
Official title:
An International Observational Study to Characterize Adults With Influenza or Other Targeted Respiratory Viruses
Verified date | August 2017 |
Source | University of Minnesota - Clinical and Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 11719 |
Est. completion date | May 12, 2017 |
Est. primary completion date | May 12, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness. |
Country | Name | City | State |
---|---|---|---|
Argentina | CEMIC | Buenos Aires | |
Argentina | FUNCEI | Buenos Aires | |
Argentina | Hospital General de Agudos JM Ramos Mejia | Buenos Aires | |
Argentina | Hospital Italiano de Buenos Aires | Buenos Aires | |
Argentina | Hospital Privado Centro Medico de Cordoba | Cordoba | |
Argentina | Hospital Rawson | Cordoba | |
Argentina | Hospital Nacional Profesor Alejandro Posadas | El Palomar | Buenos Aires |
Argentina | Hospital Interzonal General de Agudos Dr. Diego Paroissien | La Matanza | Buenos Aires |
Argentina | Instituto Medico Platense | La Plata | Buenos Aires |
Argentina | CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral) | Rosario | Santa Fe |
Argentina | Sanatorio Britanico | Rosario | Santa Fe |
Argentina | Hospital Profesor Bernardo Houssay | Vicente Lopez | Buenos Aires |
Australia | Interchange General Practice | Canberra | Australian Capital Territory |
Australia | Holdsworth House Medical Practice | Darlinghurst | New South Wales |
Australia | Prahran Market Clinic | Melbourne | Victoria |
Australia | Northside Clinic | North Fitzroy | Victoria |
Australia | Westmead Hospital | Westmead | New South Wales |
Belgium | Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre) | Brussels | |
Belgium | Practimed Medisch Centrum Tessenderlo | Tessenderlo | |
Chile | Clinica Alemana | Santiago | |
Chile | Fundacion Arriaran | Santiago | |
Chile | Pontificia Universidad Catolica de Chile | Santiago | |
Denmark | Arhus Universitetshospital, Skejby | Aarhus | |
Denmark | CHIP | Copenhagen | |
Denmark | Rigshospitalet, Infektionsmedicinsk ambulatorium 8622 | Copenhagen | |
Denmark | University Clinic of General Practice | Copenhagen | |
Estonia | West Tallinn Central Hospital Infectious Diseases | Tallinn | |
Germany | Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS | Bonn | |
Germany | Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV | Cologne | |
Germany | Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS | Frankfurt | |
Germany | Ifi - Studien und Projekte GmbH | Hamburg | |
Greece | 1st Dept of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital | Athens | |
Greece | 1st Respiratory Medicine Dept, Athens Hosp for Diseases of the Chest "Sotiria Hospital" | Athens | |
Greece | Evangelismos General Hospital | Athens | |
Greece | Hippokration University General Hospital of Athens | Athens | |
Japan | National Hospital Organization Nagoya Medical Center | Nagoya | |
Peru | Asociacion Civil IMPACTA Salud y Educacion | Lima | |
Peru | Hospital Nacional Arzobispo Loayza | Lima | |
Peru | Hospital Nacional Edgardo Rebagliati Martins | Lima | |
Peru | Hospital Nacional Guillermo Almenara Irigoyen | Lima | |
Poland | Wojewodzki Szpital Zakazny | Warsaw | |
Poland | EMC Instytut Medyczny SA | Wroclaw | |
Spain | Hospital Universitario y Politécnico La Fe | Valencia | |
Spain | Hospital Txagorritxu | Vitoria-Gasteiz | |
Thailand | Chulalongkorn University Hospital | Bangkok | |
Thailand | Khon Kaen University, Srinagarind Hospital | Khon Kaen | |
Thailand | Bamrasnaradura Institute | Nonthaburi | |
United Kingdom | Bradford Teaching Hospitals NHS Foundation Trust | Bradford | West Yorkshire |
United Kingdom | Churchill Hospital | Headington | Oxford |
United Kingdom | St James's University Hospital | Leeds | West Yorkshire |
United Kingdom | Norfolk and Norwich University Hospital | Norwich | Norfolk |
United States | UNC AIDS Clinical Trials Unit | Chapel Hill | North Carolina |
United States | University of Tennessee College of Medicine | Chattanooga | Tennessee |
United States | University of Illinois at Chicago | Chicago | Illinois |
United States | Denver Public Health | Denver | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Duke University | Durham | North Carolina |
United States | University of North Texas Health Science Center | Fort Worth | Texas |
United States | Houston AIDS Research Team | Houston | Texas |
United States | Cornell CRS | New York | New York |
United States | New Jersey Medical School Adult Clinical Research Center | Newark | New Jersey |
United States | Infectious Diseases Associates NW FL, PA | Pensacola | Florida |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | UCSD Antiviral Research Center | San Diego | California |
United States | Newland Immunology Center of Excellence (NICE) | Southfield | Michigan |
United States | Bronx-Lebanon Hospital Center | The Bronx | New York |
United States | George Washington Medical Faculty Associates | Washington, D.C. | District of Columbia |
United States | Washington DC VA Medical Center | Washington, D.C. | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute | National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) |
United States, Argentina, Australia, Belgium, Chile, Denmark, Estonia, Germany, Greece, Japan, Peru, Poland, Spain, Thailand, United Kingdom,
Drosten C, Seilmaier M, Corman VM, Hartmann W, Scheible G, Sack S, Guggemos W, Kallies R, Muth D, Junglen S, Müller MA, Haas W, Guberina H, Röhnisch 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. — View Citation
Guery B, Poissy J, el Mansouf L, Séjourné 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. Erratum in: Lancet. 2013 Jun 29;381(9885):2254. — View Citation
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. Erratum in: N Engl J Med. 2009 Jul 2;361(1):102. — View Citation
World Health Organization (WHO), Severe Acute Respiratory Syndrome (SARS), www.who.int/csr/sars/, accessed 26 August 2013
World Health Organization (WHO), www.who.int/, accessed 26 August 2013
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death or Hospitalization | Death or hospitalization within 14 days of enrollment or the development of one severe complication. | 14-day period following enrollment | |
Secondary | Days of work/school lost, duration of symptoms, use of antivirals | 14 days |