Respiratory Virus Hospitalization Study (FLU 003 Plus)

Sponsor

University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT01056185

Collaborator

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

1,000

Enrollment

Locations

161

Anticipated Duration (Months)

15.9

Patients Per Site

0.1

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 estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. 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. The current version of the protocol (released in August 2013) 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 Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)

Detailed Description

The purpose of this observational study is to describe the characteristics and outcomes over a 60-day follow-up period of participants with influenza virus infection (including influenza A subtypes such as H3N2 and 2009 H1N1, or influenza B), or a targeted non-influenza respiratory virus, who are hospitalized with severe illness and/or complications in geographically diverse locations.

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.

The information used from this study on participants with influenza and novel respiratory virus infections will be rapidly analyzed and shared broadly in order to guide policymakers and to design future studies.

Approximately 500 patients with influenza will be enrolled each year at an estimated 75 sites which are in geographically diverse locations across several continents.

Study Plan:

Participants who meet the eligibility criteria will be enrolled at participating clinical sites.
Patients with a diagnosis of influenza (confirmed or suspected), who are hospitalized with complications or severe disease, will be enrolled.
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 sample and lower respiratory tract sample, if appropriate. The respiratory specimens will be sent for central reverse transcriptase polymerase chain reaction (RT-PCR) testing for influenza.
For participants who are still hospitalized, and not intubated, 5 to 7 days after enrollment an additional upper respiratory sample is obtained.
Status will be re-assessed at approximately 28 days and 60 days after enrollment and another blood sample for serum and plasma will obtained at both time points.
For participants who are mechanically ventilated additional upper and lower respiratory tract specimens will be obtained at specific timepoints.

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 of qualifying studies is 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 severe influenza.

Participating FLU 003 Plus sites are given the option to also participate in INSIGHT Genomics which requires a separate protocol registration. Participants, once consented to FLU 003 Plus, will be offered the option to also consent to INSIGHT Genomics which includes a single whole blood sample collection. Participation in FLU 003 Plus will not be compromised if a participant opts not to participate in INSIGHT Genomics.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2009

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

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 East Respiratory Syndrome Coronavirus
Novel Respiratory Virus-2 SARS-CoV (Severe Acute Respiratory Syndrome Coronavirus)

Outcome Measures

Primary Outcome Measures

Death [60-day period following enrollment]

Secondary Outcome Measures

Recovery from influenza illness (including days lost from normal activities) duration of hospitalization, days in intensive care, days of mechanical ventilation, days of dialysis, pregnancy outcome [approximately 60 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 been admitted to hospital
Have a signed informed consent by participant or surrogate/representative
Have a local diagnosis (confirmed or suspected) of influenza, or of a targeted non-influenza viral respiratory infection*, resulting in (or extending a previous) hospitalization
A list of targeted non-influenza respiratory viruses is maintained on the INSIGHT website.

Exclusion Criteria:

Current imprisonment, or compulsory detention (involuntary incarceration) for treat 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	George Washington Medical Faculty Associates	Washington	District of Columbia	United States	20037
3	Washington DC VA Medical Center	Washington	District of Columbia	United States	20422
4	University of Illinois at Chicago	Chicago	Illinois	United States	60612
5	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
6	Baystate Infectious Diseases Clinical Research	Springfield	Massachusetts	United States	01199
7	Henry Ford Health System	Detroit	Michigan	United States	48202
8	Mayo Clinic	Rochester	Minnesota	United States	55905
9	Cooper University Hospital	Camden	New Jersey	United States	08103
10	New Jersey Medical School Adult Clinical Research Center	Newark	New Jersey	United States	07103
11	Montefiore Medical Center	Bronx	New York	United States	10467
12	Cornell CRS	New York	New York	United States	10010
13	Duke University	Durham	North Carolina	United States	27710
14	The Ohio State University Medical Center	Columbus	Ohio	United States	43210
15	Miami Valley Hospital	Dayton	Ohio	United States	45409
16	University of Tennessee College of Medicine	Chattanooga	Tennessee	United States	37403
17	Virginia Commonwealth University	Richmond	Virginia	United States	23298
18	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
19	Hospital Nacional Profesor Alejandro Posadas	El Palomar	Buenos Aires	Argentina
20	Instituto Medico Platense	La Plata	Buenos Aires	Argentina
21	Hospital Universitario Austral	Pilar	Buenos Aires	Argentina
22	Hospital Profesor Bernardo Houssay	Vicente Lopez	Buenos Aires	Argentina
23	Sanatorio Britanico	Rosario	Santa Fe	Argentina
24	CEMIC	Buenos Aires		Argentina
25	Hospital General de Agudos JM Ramos Mejia	Buenos Aires		Argentina
26	Hospital Interzonal General de Agudos Dr. Diego Paroissien	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	St. Vincent's Hospital	Darlinghurst	New South Wales	Australia	2010
31	Westmead Hospital	Westmead	New South Wales	Australia	2145
32	The Alfred Hospital	Melbourne	Victoria	Australia	3004
33	Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)	Brussels		Belgium
34	Clinica Alemana	Santiago		Chile
35	Fundacion Arriaran	Santiago		Chile
36	Arhus Universitetshospital, Skejby	Aarhus		Denmark
37	CHIP	Copenhagen		Denmark
38	Hvidovre University Hospital, Department of Infectious Diseases	Hvidovre		Denmark
39	Odense University Hospital	Odense		Denmark
40	Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS	Bonn		Germany
41	Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV	Cologne		Germany
42	Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS	Frankfurt		Germany
43	1st Dept of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital	Athens		Greece
44	1st Respiratory Medicine Dept, Athens Hosp for Diseases of the Chest "Sotiria Hospital"	Athens		Greece
45	Evangelismos General Hospital	Athens		Greece
46	Hippokration University General Hospital of Athens	Athens		Greece
47	Hospital Nacional Arzobispo Loayza	Lima		Peru	01
48	Hospital Nacional Guillermo Almenara Irigoyen	Lima		Peru	13
49	Hospital Clinico San Carlos	Madrid		Spain
50	Hospital La Paz	Madrid		Spain
51	Hospital Universitario Gregorio Mara�on	Madrid		Spain
52	Hospital Universitario Infanta Leonor	Madrid		Spain
53	Hospital Txagorritxu	Vitoria-Gasteiz		Spain
54	Chulalongkorn University Hospital	Bangkok		Thailand	10330
55	Khon Kaen University, Srinagarind Hospital	Khon Kaen		Thailand	40002
56	Bamrasnaradura Institute	Nonthaburi		Thailand	11000
57	Heatherwood and Wexham Park Hospitals NHS Foundation Trust	Slough	Berkshire	United Kingdom
58	Brighton and Sussex University Hospitals NHS Trust	Brighton	East Sussex	United Kingdom	BN2 1ES
59	Churchill Hospital	Headington	Oxford	United Kingdom	OX3 9LJ
60	Sheffield Teaching Hospital NHS Foundation Trust	Sheffield	South Yorkshire	United Kingdom	S10 2JF
61	Bradford Teaching Hospitals NHS Foundation Trust	Bradford	West Yorkshire	United Kingdom	BD9 6RJ
62	St James's University Hospital	Leeds	West Yorkshire	United Kingdom	LS9 7TF
63	Newcastle General Hospital	Newcastle upon Tyne		United Kingdom	NE4 6BE