Respiratory Virus Outpatient Study (FLU 002 Plus)

Influenza and Other Novel Respiratory Viruses Clinical Trial

Official title:

An International Observational Study to Characterize Adults With Influenza or Other Targeted Respiratory Viruses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056354
• Other study ID #: 0603M83587 FLU 002
• Secondary ID: HHSN261200800001
• Status: Completed
• Phase: N/A
• First received: January 25, 2010
• Last updated: August 15, 2017
• Start date: August 2009
• Est. completion date: May 12, 2017

Study information

• Verified date: August 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Influenza and Other Novel Respiratory Viruses
• Influenza, Human

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Chile,  Denmark,  Estonia,  Germany,  Greece,  Japan,  Peru,  Poland,  Spain,  Thailand,  United Kingdom, 

References & Publications (5)

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

Outcome

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

External Links

•   INSIGHT website