Respiratory Virus Hospitalization Study (FLU 003 Plus)
a study on Influenza
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.
An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses
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.
- 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.
Influenza Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) flu swine flu respiratory virus hospitalization MERS-CoV SARS-CoV Syndrome Virus Diseases Influenza, Human Severe Acute Respiratory Syndrome Coronavirus Infections Novel Respiratory Virus-1 Novel Respiratory Virus-2
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- Current imprisonment, or compulsory detention (involuntary incarceration) for treat of a psychiatric or physical illness.
- UCSD Antiviral Research Center accepting new patients
San Diego California 92103-8208 United States
- Mayo Clinic accepting new patients
Rochester Minnesota 55905 United States
- University of Illinois at Chicago accepting new patients
Chicago Illinois 60612 United States
- Medical College of Wisconsin accepting new patients
Milwaukee Wisconsin 53226 United States
- University of Tennessee College of Medicine accepting new patients
Chattanooga Tennessee 37403 United States
- Miami Valley Hospital accepting new patients
Dayton Ohio 45409 United States
- The Ohio State University Medical Center accepting new patients
Columbus Ohio 43210 United States
- Henry Ford Health System accepting new patients
Detroit Michigan 48202 United States
- Duke University accepting new patients
Durham North Carolina 27710 United States
- Virginia Commonwealth University accepting new patients
Richmond Virginia 23298 United States
- George Washington Medical Faculty Associates accepting new patients
Washington District of Columbia 20037 United States
- Washington DC VA Medical Center accepting new patients
Washington District of Columbia 20422 United States
- Cooper University Hospital accepting new patients
Camden New Jersey 08103 United States
- New Jersey Medical School Adult Clinical Research Center accepting new patients
Newark New Jersey 07103 United States
- Cornell CRS accepting new patients
New York New York 10010 United States
- Montefiore Medical Center accepting new patients
Bronx New York 10467 United States
- Baystate Infectious Diseases Clinical Research accepting new patients
Springfield Massachusetts 01199 United States
- Brigham and Women's Hospital accepting new patients
Boston Massachusetts 02115 United States
- Hospital Nacional Arzobispo Loayza accepting new patients
Lima 01 Peru
- Hospital Nacional Guillermo Almenara Irigoyen accepting new patients
Lima 13 Peru
- Heatherwood and Wexham Park Hospitals NHS Foundation Trust accepting new patients
Slough Berkshire United Kingdom
- Brighton and Sussex University Hospitals NHS Trust accepting new patients
Brighton East Sussex BN2 1ES United Kingdom
- Churchill Hospital accepting new patients
Headington Oxford OX3 9LJ United Kingdom
- Sheffield Teaching Hospital NHS Foundation Trust accepting new patients
Sheffield South Yorkshire S10 2JF United Kingdom
- Bradford Teaching Hospitals NHS Foundation Trust accepting new patients
Bradford West Yorkshire BD9 6RJ United Kingdom
- St James's University Hospital accepting new patients
Leeds West Yorkshire LS9 7TF United Kingdom
- Newcastle General Hospital accepting new patients
Newcastle upon Tyne NE4 6BE United Kingdom
- Clinica Alemana currently not accepting new patients, but might later
- Fundacion Arriaran currently not accepting new patients, but might later
- Arhus Universitetshospital, Skejby accepting new patients
- CHIP accepting new patients
- Hvidovre University Hospital, Department of Infectious Diseases accepting new patients
- Odense University Hospital accepting new patients
- Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre) accepting new patients
- Hospital Nacional Profesor Alejandro Posadas in progress, not accepting new patients
El Palomar Buenos Aires Argentina
- Instituto Medico Platense accepting new patients
La Plata Buenos Aires Argentina
- Hospital Universitario Austral accepting new patients
Pilar Buenos Aires Argentina
- Hospital Profesor Bernardo Houssay accepting new patients
Vicente Lopez Buenos Aires Argentina
- Sanatorio Britanico accepting new patients
Rosario Santa Fe Argentina
- CEMIC accepting new patients
Buenos Aires Argentina
- Hospital General de Agudos JM Ramos Mejia accepting new patients
Buenos Aires Argentina
- Hospital Interzonal General de Agudos Dr. Diego Paroissien in progress, not accepting new patients
Buenos Aires Argentina
- Hospital Italiano de Buenos Aires accepting new patients
Buenos Aires Argentina
- Hospital Privado Centro Medico de Cordoba accepting new patients
- Hospital Rawson accepting new patients
- Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS accepting new patients
- Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV accepting new patients
- Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS accepting new patients
- Hospital Clinico San Carlos accepting new patients
- Hospital La Paz accepting new patients
- Hospital Universitario Gregorio Mara�on accepting new patients
- Hospital Universitario Infanta Leonor accepting new patients
- Hospital Txagorritxu accepting new patients
- 1st Dept of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital accepting new patients
- 1st Respiratory Medicine Dept, Athens Hosp for Diseases of the Chest "Sotiria Hospital" accepting new patients
- Evangelismos General Hospital accepting new patients
- Hippokration University General Hospital of Athens accepting new patients
- St. Vincent's Hospital accepting new patients
Darlinghurst New South Wales 2010 Australia
- Westmead Hospital accepting new patients
Westmead New South Wales 2145 Australia
- The Alfred Hospital accepting new patients
Melbourne Victoria 3004 Australia
- Chulalongkorn University Hospital accepting new patients
Bangkok 10330 Thailand
- Khon Kaen University, Srinagarind Hospital accepting new patients
Khon Kaen 40002 Thailand
- Bamrasnaradura Institute accepting new patients
Nonthaburi 11000 Thailand
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.