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Surveillance of Influenza Virus Shedding and Immunologic Response in Immunocompromised Children and Young Adults


N/A
N/A
21 Years
Not Enrolling
Both
Influenza Virus

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Trial Information

Surveillance of Influenza Virus Shedding and Immunologic Response in Immunocompromised Children and Young Adults


This study aims to do the following;

- To evaluate the frequency of influenza virus infections due to various subtypes in
immunocompromised children and young adults at SJCRH

- To describe and compare the clinical course and outcome of pandemic H1N1 influenza
infection with that due to other influenza virus subtypes in immunocompromised children
and young adults.

- To evaluate the duration of influenza virus shedding in immunocompromised children and
young adults.

- To evaluate the immunologic response to natural infection with various subtypes of
influenza virus including the pandemic H1N1 influenza A virus.

- To evaluate the viral resistance to antiviral agents in relation to antiviral therapy.

- To compare accuracy of rapid methods for influenza A subtyping and for determination of
antiviral resistance.


Inclusion Criteria:



- Age <= 21 years of age at the time of entry into the study.

- Body weight of 13 kg or greater

- An immunosuppressed state due to cancer, sickle cell disease, HIV, or receipt of stem
cell transplant

- Presentation with acute respiratory illness defined as recent onset of rhinorrhea,
nasal and sinus congestion, pharyngitis, coryza, sinusitis, otitis media, dyspnea or
shortness of breath, cough and/or a new radiographic pulmonary infiltrates.

- Proven influenza virus infection by virological testing of respiratory specimens
using Polymerase Chain reaction (PCR) assay, direct antigen detection assay, or viral
culture.

Exclusion Criteria:

- Inability or unwillingness of research participant or legal guardian to give written
informed consent.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evaluate the frequency of influenza virus infections due to various subtypes in immunocompromised children and young adults at SJCRH

Outcome Time Frame:

one year after enrollment

Safety Issue:

No

Principal Investigator

Hana Hakim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

FLUSRV

NCT ID:

NCT00998803

Start Date:

October 2009

Completion Date:

June 2012

Related Keywords:

  • Influenza Virus
  • Influenza virus
  • Influenza, Human
  • Virus Diseases

Name

Location
St . Jude Children's Research Hospital Memphis, Tennessee  38105