Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-01 @ 5:13 PM
Study NCT ID:
NCT00998803
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2009-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance of Influenza Virus Shedding and Immunologic Response in Immunocompromised Children and Young Adults
Sponsor:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
Surveillance of Influenza Virus Shedding and Immunologic Response in Immunocompromised Children and Young Adults
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: