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A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents

NCT02352389 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2023-12-12

No results posted yet for this study

Summary

The purpose of the proposed study is to gather critical information that may be useful in designing effective prevention and treatment strategies for control of seasonal influenza and an influenza pandemic. In particular, the critical questions are related to the virus' ability to adapt to efficient replication and spread in humans.

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.

Conditions

  • Influenza, Human

Interventions

OTHER

Blood sample

Blood samples will be drawn and analyzed at Day 0, 7, 14, 21, and 28

OTHER

Nasal swab

Obtained on Day 0, 7, 14, 21 and 28.

OTHER

Oropharyngeal swab

Obtained on Day 0, 7, 14, 21 and 28.

OTHER

Stool sample

Obtained on Day 0, 7, 14, 21 and 28.

OTHER

Symptom checklist

Obtained on Day 0, 7, 14, 21 and 28.

Sponsors & Collaborators

Principal Investigators

  • Elisabeth E. Adderson, MD, MSc · St. Jude Children's Research Hospital

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-30
Primary Completion
2022-12-08
Completion
2022-12-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02352389 on ClinicalTrials.gov