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

NCT00998803 | Completed

• 1 other identifier: FLUSRV
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza Virus

Keywords

Influenza virus

Outcome Measures

Primary Outcomes (1)

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

  one year after enrollment

Secondary Outcomes (5)

• 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

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

  one year after enrollment

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

  one year after enrollment

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

  one year after enrollment

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

  one year after enrollment

Study Arms (1)

Immunocompromised participants

Immunocompromised (\<= 21 years of age) due to cancer, receipt of stem cell transplant, human immunodeficiency virus (HIV) or Sickle cell disease

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Inability or unwillingness of research participant or legal guardian to give written informed consent.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

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.

Study Officials

• Hana Hakim, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: October 21, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 1, 2012

Record last verified: 2012-10

Locations

US (1)