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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00533182
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : September 8, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

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
Viral Infections Respiratory Infections

Detailed Description:

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, and the NIH Clinical Center. Patients with known or suspected influenza will be evaluated by recording their symptoms, collecting their blood and nasal 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 mucosal samples, 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.

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Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influenza in the Non-immunocompromised and Immunocompromised Host
Actual Study Start Date : January 3, 2008

Resource links provided by the National Library of Medicine


Group/Cohort
Immunocompromised
Immunocompromised individuals
Non-Immunocompromised
Non-immunocompromised individuals
Pregnant
Pregnant women



Primary Outcome Measures :
  1. The purpose of this study is to evaluate immunocompromised andnon-immunocompromised individuals who become infected with influenza virus. [ Time Frame: 1 year ]
    To better understand the impact influenza has on the overall health of patients



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with known or suspected influenza infection: NIH Patients, Non-NIH Outpatients, Hospitalized Patients at the Washington Hospital Center, Non-Hospitalized Patients at the Washington Hospital Center. Healthy Pregnant Women (Control): Patients at the Washington Hospital Center
Criteria
  • INCLUSION CRITERIA:

    1. Greater than or equal to 2 years old
    2. Participant or (LAR) able and willing to complete the consent/assent process and be willing to comply with study procedures
    3. Suspected of having influenza by clinical diagnosis or have a positive clinical diagnostic test for influenza (rapid test molecular test, or culture) within the past 2 months.
    4. Agrees to undergo multiple nasal mucosal sample collections by nasal wash, swab, and/or synthetic absorptive matrix (SAM)
    5. Willing to have blood and nasal samples stored for future use

EXCLUSION CRITERIA:

Participants will not be enrolled in this study if the following criterion applies or is satisfied:

1. Any condition that, in the judgment of the investigator is a contraindication to protocol participation.


Information from the National Library of Medicine

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


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Matthew J Memoli, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00533182    
Other Study ID Numbers: 070229
07-I-0229
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: August 25, 2022
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Pregnant
Children
Adults
Flu
Infection
Natural History
Influenza Infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Influenza, Human
Respiratory Tract Infections
Virus Diseases
Disease Attributes
Pathologic Processes
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases