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Influenza in People With Normal and Weakened Immune Systems

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT00533182
First received: September 20, 2007
Last updated: November 11, 2014
Last verified: March 2014

September 20, 2007
November 11, 2014
September 2007
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Complete list of historical versions of study NCT00533182 on ClinicalTrials.gov Archive Site
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Influenza in People With Normal and Weakened Immune Systems
Influenza in the Non-immunocompromised and Immunocompromised Host

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.

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.

Observational
Time Perspective: Prospective
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  • Influenza, Human
  • Immunocompromised Host
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1300
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  • INCLUSION CRITERIA:

To be included in the protocol-based study, participants must satisfy all of the following requirements:

  1. Greater than or equal to 2 years old
  2. Patient or designated guardian 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 or culture) within the past 2 months.
  4. Agrees to undergo multiple nasal wash or swabs.
  5. Willing to have blood and nasal samples stored for future use

EXCLUSION CRITERIA:

Patients 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 or impairs a volunteer s ability to give informed consent.

Both
2 Years and older
Yes
Contact: Matthew J Memoli, M.D. (301) 443-5971 mm982v@nih.gov
United States
 
NCT00533182
070229, 07-I-0229
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National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Matthew J Memoli, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP