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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00998803
First received: October 19, 2009
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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.


Condition
Influenza Virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surveillance of Influenza Virus Shedding and Immunologic Response in Immunocompromised Children and Young Adults

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the duration of influenza viral shedding in immunocompromised children and young adults. [ Time Frame: one year after enrollment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the viral resistance to antiviral agents in relation to antiviral therapy. [ Time Frame: one year after enrollment ] [ Designated as safety issue: No ]
  • To compare accuracy of rapid methods for influenza A subtyping and for determination of antiviral resistance. [ Time Frame: one year after enrollment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
  • Nasopharyngeal swab collection is as follows: after tilting the tip of the patient's nose upward, a swab is inserted through the nostril along the floor of the nose into the nasopharynx. Then, the swab is gently rotated, removed and placed in its receptacle for delivery to the laboratory.
  • Respiratory specimens will be stored at 2-8ºC and processed within 24-48 hours of collection. Serum and whole blood for immune assays will be frozen at -20ºC or in liquid nitrogen until processed in batched assays.
  • All blood specimens will be sent to the laboratory for immunologic assays.

Enrollment: 9
Study Start Date: October 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Immunocompromised participants
Immunocompromised (<= 21 years of age) due to cancer, receipt of stem cell transplant, human immunodeficiency virus (HIV) or Sickle cell disease

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.
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This is a prospective surveillance study that evaluates research participants who are ≤ 21 years of age and diagnosed at SJCRH with acute respiratory illness due to influenza virus confirmed by antigen detection, PCR or viral culture of clinical respiratory specimens.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998803

Locations
United States, Tennessee
St . Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Hana Hakim, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00998803     History of Changes
Other Study ID Numbers: FLUSRV
Study First Received: October 19, 2009
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Influenza virus

Additional relevant MeSH terms:
Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014