Surveillance of Influenza Virus Shedding and Immunologic Response in Immunocompromised Children and Young Adults
N/A
21 Years
Both
Influenza Virus
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 |
