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

Influenza Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998803
• Other study ID #: FLUSRV
• Status: Completed
• Phase: N/A
• First received: October 19, 2009
• Last updated: October 30, 2012
• Start date: October 2009
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Influenza virus infections are a major cause of morbidity and mortality. The limited existing knowledge about the impact of influenza in immunocompromised patients suggests that they are at increased risk of influenza virus acquisition, of developing complications and of prolonged illness and viral shedding. However, some other data about the effect of antiviral agents on the infection course, and risk of resistance in immunocompromised children are lacking. The emergence of the pandemic H1N1 swine-origin influenza A virus has generated an additional need to study the epidemiology, clinical course and outcome of influenza infections in immunocompromised children. This study proposed to conduct a prospective observational clinical study to answer these questions.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza Virus
• Influenza, Human

Locations

Country	Name	City	State
United States	St . Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the frequency of influenza virus infections due to various subtypes in immunocompromised children and young adults at SJCRH		one year after enrollment	No
Secondary	To describe and compare the clinical course and outcome of pandemic H1N1 influenza virus infection with that due to other influenza virus subtypes in immunocompromised children and young adults.		one year after enrollment	No
Secondary	To evaluate the duration of influenza viral shedding in immunocompromised children and young adults.		one year after enrollment	No
Secondary	To evaluate the immunologic response to natural infection with various subtypes of influenza virus including the pandemic H1N1 virus.		one year after enrollment	No
Secondary	To evaluate the viral resistance to antiviral agents in relation to antiviral therapy.		one year after enrollment	No
Secondary	To compare accuracy of rapid methods for influenza A subtyping and for determination of antiviral resistance.		one year after enrollment	No

External Links

•   St. Jude Children's Research Hospital