Respiratory Virus Outpatient Study (FLU 002 Plus)

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT01056354

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH), National Institutes of Health (NIH) (NIH)

11,719

Enrollment

Locations

93.3

Duration (Months)

172.3

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Influenza and Other Novel Respiratory Viruses

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

Study Type:

Observational

Actual Enrollment :

11719 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

May 12, 2017

Actual Study Completion Date :

May 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

Death or Hospitalization [14-day period following enrollment]
Death or hospitalization within 14 days of enrollment or the development of one severe complication.

Secondary Outcome Measures

Days of work/school lost, duration of symptoms, use of antivirals [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Antiviral Research Center	San Diego	California	United States	92103-8208
2	Denver Public Health	Denver	Colorado	United States	80204
3	George Washington Medical Faculty Associates	Washington, D.C.	District of Columbia	United States	20037
4	Washington DC VA Medical Center	Washington, D.C.	District of Columbia	United States	20422
5	Infectious Diseases Associates NW FL, PA	Pensacola	Florida	United States	32503
6	University of Illinois at Chicago	Chicago	Illinois	United States	60612
7	Henry Ford Health System	Detroit	Michigan	United States	48202
8	Newland Immunology Center of Excellence (NICE)	Southfield	Michigan	United States	48075
9	New Jersey Medical School Adult Clinical Research Center	Newark	New Jersey	United States	07103
10	Cornell CRS	New York	New York	United States	10010
11	Bronx-Lebanon Hospital Center	The Bronx	New York	United States	10457
12	UNC AIDS Clinical Trials Unit	Chapel Hill	North Carolina	United States	27514
13	Duke University	Durham	North Carolina	United States	27710
14	University of Tennessee College of Medicine	Chattanooga	Tennessee	United States	37403
15	University of North Texas Health Science Center	Fort Worth	Texas	United States	76107
16	Houston AIDS Research Team	Houston	Texas	United States	77030
17	Virginia Commonwealth University	Richmond	Virginia	United States	23298
18	Hospital Nacional Profesor Alejandro Posadas	El Palomar	Buenos Aires	Argentina
19	Hospital Interzonal General de Agudos Dr. Diego Paroissien	La Matanza	Buenos Aires	Argentina
20	Instituto Medico Platense	La Plata	Buenos Aires	Argentina
21	Hospital Profesor Bernardo Houssay	Vicente Lopez	Buenos Aires	Argentina
22	CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral)	Rosario	Santa Fe	Argentina
23	Sanatorio Britanico	Rosario	Santa Fe	Argentina
24	CEMIC	Buenos Aires		Argentina
25	FUNCEI	Buenos Aires		Argentina
26	Hospital General de Agudos JM Ramos Mejia	Buenos Aires		Argentina
27	Hospital Italiano de Buenos Aires	Buenos Aires		Argentina
28	Hospital Privado Centro Medico de Cordoba	Cordoba		Argentina
29	Hospital Rawson	Cordoba		Argentina
30	Interchange General Practice	Canberra	Australian Capital Territory	Australia	2601
31	Holdsworth House Medical Practice	Darlinghurst	New South Wales	Australia	2010
32	Westmead Hospital	Westmead	New South Wales	Australia	2145
33	Prahran Market Clinic	Melbourne	Victoria	Australia	3181
34	Northside Clinic	North Fitzroy	Victoria	Australia	3068
35	Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)	Brussels		Belgium
36	Practimed Medisch Centrum Tessenderlo	Tessenderlo		Belgium
37	Clinica Alemana	Santiago		Chile
38	Fundacion Arriaran	Santiago		Chile
39	Pontificia Universidad Catolica de Chile	Santiago		Chile
40	Arhus Universitetshospital, Skejby	Aarhus		Denmark
41	CHIP	Copenhagen		Denmark
42	Rigshospitalet, Infektionsmedicinsk ambulatorium 8622	Copenhagen		Denmark
43	University Clinic of General Practice	Copenhagen		Denmark
44	West Tallinn Central Hospital Infectious Diseases	Tallinn		Estonia
45	Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS	Bonn		Germany
46	Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV	Cologne		Germany
47	Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS	Frankfurt		Germany
48	Ifi - Studien und Projekte GmbH	Hamburg		Germany
49	1st Dept of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital	Athens		Greece
50	1st Respiratory Medicine Dept, Athens Hosp for Diseases of the Chest "Sotiria Hospital"	Athens		Greece
51	Evangelismos General Hospital	Athens		Greece
52	Hippokration University General Hospital of Athens	Athens		Greece
53	National Hospital Organization Nagoya Medical Center	Nagoya		Japan	460-0001
54	Hospital Nacional Arzobispo Loayza	Lima		Peru	01
55	Asociacion Civil IMPACTA Salud y Educacion	Lima		Peru	04
56	Hospital Nacional Edgardo Rebagliati Martins	Lima		Peru	11
57	Hospital Nacional Guillermo Almenara Irigoyen	Lima		Peru	13
58	Wojewodzki Szpital Zakazny	Warsaw		Poland
59	EMC Instytut Medyczny SA	Wroclaw		Poland
60	Hospital Universitario y Politécnico La Fe	Valencia		Spain	46026
61	Hospital Txagorritxu	Vitoria-Gasteiz		Spain
62	Chulalongkorn University Hospital	Bangkok		Thailand	10330
63	Khon Kaen University, Srinagarind Hospital	Khon Kaen		Thailand	40002
64	Bamrasnaradura Institute	Nonthaburi		Thailand	11000
65	Norfolk and Norwich University Hospital	Norwich	Norfolk	United Kingdom	NR4 7UY
66	Churchill Hospital	Headington	Oxford	United Kingdom	OX3 9LJ
67	Bradford Teaching Hospitals NHS Foundation Trust	Bradford	West Yorkshire	United Kingdom	BD9 6RJ
68	St James's University Hospital	Leeds	West Yorkshire	United Kingdom	LS9 7TF