Influenza in People With Normal and Weakened Immune Systems
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00533182|
Recruitment Status : Recruiting
First Posted : September 21, 2007
Last Update Posted : January 9, 2018
This study will evaluate how the immune system responds to influenza infection and compare how the infection differs in patients with a weakened immune system versus those with a healthy immune system.
Patients at the NIH Clinical Center who are older than 2 years of age and who are diagnosed with influenza A or B may be eligible for this study. Patients with healthy immune systems and weakened immune systems are included.
Participants answer questions about how they are feeling and have a physical examination to evaluate their symptoms. Blood and nasal fluid are collected on the first day and then every other day for a total of 8 days. Nasal fluid is collected by either inserting a small tube in the nose and washing the nose with salt water and collecting the fluid obtained, or by rubbing the inside of the nose with a swab. Physical examinations are repeated on the days that blood and nasal fluid are collected.
|Condition or disease|
Influenza viruses cause significant morbidity each year, and past epidemics and pandemics have caused significant mortality. The impact influenza has or could have on the increasing number of patients who are immunocompromised due to acute and chronic diseases as well as immunosuppressive therapies is largely unknown. Limited information is available about the innate immune response to influenza and how chronic illness and immunosuppression may affect the immune response to the virus in comparison to that seen in normal hosts.
We will evaluate both immunocompromised and non-immunocompromised (control group) patients from the local community, Washington Hospital Center, and the NIH Clinical Center. Patients with known or suspected influenza will be evaluated by recording their symptoms, collecting their blood and nasal fluid specimens, and isolating their viruses. Each patient s infection will be mapped by performing genomic analysis of the viral isolates collected during the patient s infection (which will include analysis of sequences known to confer resistance to antiviral medication), measuring cytokine levels in blood and nasal fluid, and measuring influenza-specific antibody responses. Correlation of these results with clinical symptoms and clinical outcomes will be evaluated. Elucidation of these responses and the genomic changes the virus may undergo during infection and treatment for influenza in both normal and immunocompromised patients may help to better understand the impact influenza has on the overall health of patients, as well as what strategies may be performed to better protect or treat patients during the emergence of a new pandemic.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Influenza in the Non-immunocompromised and Immunocompromised Host|
|Study Start Date :||September 19, 2007|
- The purpose of this study is to evaluate immunocompromised andnon-immunocompromised individuals who become infected with influenza virus. [ Time Frame: ongiong ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533182
|Contact: Matthew J Memoli, M.D.||(301) email@example.com|
|United States, District of Columbia|
|Washington Hospital Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Matthew J Memoli, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|