Influenza VirusNCT00998803
Surveillance of Influenza Virus Shedding and Immunologic Response in Immunocompromised Children and Young Adults
An observational study of Influenza Virus, run by St. Jude Children's Research Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Influenza Virus
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2012
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Inability or unwillingness of research participant or legal guardian to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
St . Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Influenza Virus
- Keywords
- Influenza virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immunocompromised participants | Immunocompromised (<= 21 years of age) due to cancer, receipt of stem cell transplant, human immunodeficiency virus (HIV) or Sickle cell disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the frequency of influenza virus infections due to various subtypes in immunocompromised children and young adults at SJCRH
Measured: 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.
Measured: one year after enrollment
To evaluate the duration of influenza viral shedding in immunocompromised children and young adults.
Measured: one year after enrollment
To evaluate the immunologic response to natural infection with various subtypes of influenza virus including the pandemic H1N1 virus.
Measured: one year after enrollment
To evaluate the viral resistance to antiviral agents in relation to antiviral therapy.
Measured: one year after enrollment
To compare accuracy of rapid methods for influenza A subtyping and for determination of antiviral resistance.
Measured: one year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VirusStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hana Hakim, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998803
- Sponsor's protocol ID
- FLUSRV
- Status last verified
- Oct 2012
- First submitted
- 19 Oct 2009
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No