A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents
NCT ID: NCT02352389
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
16 participants
OBSERVATIONAL
2015-03-30
2022-12-08
Brief Summary
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Influenza is a contagious respiratory illness caused by influenza A and B viruses. Influenza infections result in about 230,000 hospitalizations and 36,000 deaths annually in the United States. Children with cancer are more likely to have serious influenza and complications than those who have no underlying medical problems. They are also more likely to have prolonged influenza illnesses and to shed influenza viruses from their noses for long periods of time (sometimes for months). Recent studies suggest that influenza viruses may also be carried and shed from the gastrointestinal tract. New types of influenza viruses emerge frequently through mutations that occur when the viruses replicate. These mutations allow the virus to escape from killing by the immune system and are, in large part, responsible for seasonal epidemics of influenza that occur in the fall or winter months. It is possible that viruses can mutate when they are carried in the respiratory or gastrointestinal tracts for long periods, potentially giving rise to viruses that spread more easily to other persons, cause more severe disease, lead to new influenza epidemics or make the viruses resistant to drugs used to treat influenza.
Researchers at St. Jude Children's Research Hospital want to learn about how influenza viruses mutate in immunocompromised children. They will investigate how long children with cancer carry influenza viruses in their nose, throat and gastrointestinal tract and the characteristics of any mutations that are found in these viruses.
Detailed Description
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PRIMARY OBJECTIVE:
* To determine the proportion of pediatric oncology patients with nasal and oropharyngeal shedding of influenza viruses at 7, 14, 21 and 28 days following the diagnosis of infection.
SECONDARY OBJECTIVES:
* To determine the proportion of gastrointestinal shedding of human influenza viruses.
* To determine the frequency and pattern of mutations in influenza viruses isolated from pediatric oncology patients.
* To explore the biological consequences of mutations in influenza viruses isolated from pediatric oncology patients.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Influenza
Children and young adults identified as having influenza infections by the St. Jude Children's Research Hospital diagnostic microbiology will be approached to participate in the study. Biological samples will be collected on Day 0 within 72 hours of the diagnosis of influenza, and at 7, 14, 21, and 28 days later.
Interventions: Symptom checklist, Blood sample, Nasal swab, Oropharyngeal swab, Stool sample.
Blood sample
Blood samples will be drawn and analyzed at Day 0, 7, 14, 21, and 28
Nasal swab
Obtained on Day 0, 7, 14, 21 and 28.
Oropharyngeal swab
Obtained on Day 0, 7, 14, 21 and 28.
Stool sample
Obtained on Day 0, 7, 14, 21 and 28.
Symptom checklist
Obtained on Day 0, 7, 14, 21 and 28.
Interventions
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Blood sample
Blood samples will be drawn and analyzed at Day 0, 7, 14, 21, and 28
Nasal swab
Obtained on Day 0, 7, 14, 21 and 28.
Oropharyngeal swab
Obtained on Day 0, 7, 14, 21 and 28.
Stool sample
Obtained on Day 0, 7, 14, 21 and 28.
Symptom checklist
Obtained on Day 0, 7, 14, 21 and 28.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently receiving active therapy for malignant disease at St. Jude, excepting surgical therapy only, or has received a hematopoietic stem cell transplant in the last 6 months.
* Subject has had a positive test for influenza (by direct fluorescent antibody, nucleic acid amplification test or viral culture) within 72 hrs of the time of enrollment.
* Agrees to participate in the study.
* Able to understand and comply with planned study procedures.
* Is available for all study visits.
Exclusion Criteria
* Has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
* Previous enrollment on study.
21 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Elisabeth E. Adderson, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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FLUMUT
Identifier Type: -
Identifier Source: org_study_id