Trial record 6 of 22 for:    NIAID | Open Studies | Influenza

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:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00533182
First received: September 20, 2007
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

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
Influenza, Human
Immunocompromised Host

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Influenza in the Non-immunocompromised and Immunocompromised Host

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1300
Study Start Date: September 2007
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, 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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533182

Contacts
Contact: Matthew J Memoli, M.D. (301) 443-5971 mm982v@nih.gov

Locations
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    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Matthew J Memoli, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00533182     History of Changes
Other Study ID Numbers: 070229, 07-I-0229
Study First Received: September 20, 2007
Last Updated: March 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Influenza Infection
Immunocompromised Host
Resistance Mutations
Prolonged Infection

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014