A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents
| Status: | Recruiting |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 21 |
| Updated: | 9/14/2018 |
| Start Date: | March 30, 2015 |
| End Date: | February 2020 |
| Contact: | Elisabeth E. Adderson, MD, MSc |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
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.
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.
Participants will have nasal, oral and stool specimens obtained at the time they are
diagnosed with influenza infections, and 7, 14, 21 and 28 days later. The genome of influenza
viruses that are isolated from these participants will be sequenced and compared to one
another and to standard influenza strains.
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.
diagnosed with influenza infections, and 7, 14, 21 and 28 days later. The genome of influenza
viruses that are isolated from these participants will be sequenced and compared to one
another and to standard influenza strains.
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.
Inclusion Criteria:
- Less than 22 years of age.
- 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:
- Contraindication to nasal (mid-turbinate) swabs (e.g. nasal lesion or obstruction)
- 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.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Elisabeth Adderson, MD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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