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OpenTrials
Completed

NCT Number: NCT00998803

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

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.

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Key information

Conditions

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: one year after enrollment

Secondary outcomes

  1. 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.

    Time frame: one year after enrollment

  2. To evaluate the duration of influenza viral shedding in immunocompromised children and young adults.

    Time frame: one year after enrollment

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

    Time frame: one year after enrollment

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

    Time frame: one year after enrollment

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

    Time frame: one year after enrollment

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 21, 2009
Registry last updated
Nov 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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