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Protocol Details

FLU 003 Plus: An International Observational Study to Characterize Adults Who Are Hospitalized with Influenza or Other Targeted Respiratory Viruses

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 100 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women


Respiratory Virus;
Natural History

Recruitment Keyword(s)

H1N1 Influenza A



Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Allergy and Infectious Diseases


- Influenza is a common disease and usually mild, but there are several types of flu viruses and they change over time, and some are more deadly than others. Recently, a new influenza A virus (known commonly as swine flu or H1N1) has emerged. This flu has spread rapidly around the world.

- It is important to understand the course of illness for those who have H1N1 and the characteristics of people who do not do well and who may need further treatment and care to recover from the flu. Researchers are interested in learning more about how different treatments and prior vaccination for the flu affects the course of illness in those who have contracted H1N1 flu.


- To study the immediate and long-term outcomes experienced by individuals who have been hospitalized with complications from H1N1v influenza.


- Individuals 18 years of age and older who have a confirmed diagnosis of H1N1v-type flu and have been hospitalized for complications of the disease (such as respiratory distress requiring oxygen treatment).


- Researchers will collect and evaluate patient records from eligible individuals undergoing treatment for complications of H1N1v-type influenza.

- Blood and nasal/throat swab samples will be collected as required by the researchers at the time of enrollment in the study and 28 days after enrollment.

- Researchers will contact patients 28 and 60 days after initial hospitalization, and ask questions about health and recovery. Questions may include how many days flu symptoms lasted, what treatments were required, number of days of work or school missed, whether anyone else in the patient s household came down with the flu, and whether the patient has required any further medical care

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- Age at least 18 years

- 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

* In order to be able to respond rapidly to emerging pandemics, a list of targeted non-influenza respiratory viruses is maintained on the INSIGHT website.


- Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness

- Participants who are decisionally impaired will not be eligible for this study.

- People who are pregnant will not be eligible for this study.

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Simonsen L, Higgs E, Taylor RJ, Wentworth D, Cozzi-Lepri A, Pett S, Dwyer DE, Davey R, Lynfield R, Losso M, Morales K, Glesby MJ, Weckx J, Carey D, Lane C, Lundgren J; INSIGHT FLU002 and FLU003 Study Groups. Using Clinical Research Networks to Assess Severity of an Emerging Influenza Pandemic. Clin Infect Dis. 2018 Jul 18;67(3):341-349. doi: 10.1093/cid/ciy088.

Pett SL, Kunisaki KM, Wentworth D, Griffin TJ, Kalomenidis I, Nahra R, Montejano Sanchez R, Hodgson SW, Ruxrungtham K, Dwyer D, Davey RT, Wendt CH; INSIGHT FLU003 Plus Study Group . Increased Indoleamine-2,3-Dioxygenase Activity Is Associated With Poor Clinical Outcome in Adults Hospitalized With Influenza in the INSIGHT FLU003Plus Study. Open Forum Infect Dis. 2017 Oct 25;5(1):ofx228. doi: 10.1093/ofid/ofx228. eCollection 2018 Jan.

Lynfield R, Davey R, Dwyer DE, Losso MH, Wentworth D, Cozzi-Lepri A, Herman-Lamin K, Cholewinska G, David D, Kuetter S, Ternesgen Z, Uyeki TM, Lane HC, Lundgren J, Neaton JD; INSIGHT Influenza Study Group. Outcomes of influenza A(H1N1)pdm09 virus infection: results from two international cohort studies. PLoS One. 2014 Jul 8;9(7):e101785. doi: 10.1371/journal.pone.0101785. eCollection 2014.

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Principal Investigator

Referral Contact

For more information:

Richard T. Davey Jr., M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CRC BG RM 4-1479NE
(301) 496-8029

Rosemary McConnell, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 6D44
10 Center Drive
Bethesda, Maryland 20892
(301) 761-6645

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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