Clinical trial NCT02352389: A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents
Official title: A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Keywords: Childhood
Cancer
Genetic mutations
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 16
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with nasal shedding of influenza viruses
timeFrame: Day 0
measure: Proportion of patients with nasal shedding of influenza viruses
timeFrame: Day 7
measure: Proportion of patients with nasal shedding of influenza viruses
timeFrame: Day 14
measure: Proportion of patients with nasal shedding of influenza viruses
timeFrame: Day 21
measure: Proportion of patients with nasal shedding of influenza viruses
timeFrame: Day 28
measure: Proportion of patients with oropharyngeal shedding of influenza viruses
timeFrame: Day 0
measure: Proportion of patients with oropharyngeal shedding of influenza viruses
timeFrame: Day 7
measure: Proportion of patients with oropharyngeal shedding of influenza viruses
timeFrame: Day 14
measure: Proportion of patients with oropharyngeal shedding of influenza viruses
timeFrame: Day 21
measure: Proportion of patients with oropharyngeal shedding of influenza viruses
timeFrame: Day 28
Secondary outcomes:
measure: Frequency of gastrointestinal shedding of human influenza virus
timeFrame: Day 0
measure: Frequency of gastrointestinal shedding of human influenza virus
timeFrame: Day 7
measure: Frequency of gastrointestinal shedding of human influenza virus
timeFrame: Day 14
measure: Frequency of gastrointestinal shedding of human influenza virus
timeFrame: Day 21
measure: Frequency of gastrointestinal shedding of human influenza virus
timeFrame: Day 28
measure: Frequency of mutations in influenza viruses
timeFrame: Day 0
measure: Frequency of mutations in influenza viruses
timeFrame: Day 7
measure: Frequency of mutations in influenza viruses
timeFrame: Day 14
measure: Frequency of mutations in influenza viruses
timeFrame: Day 21
measure: Frequency of mutations in influenza viruses
timeFrame: Day 28
measure: Number of mutations by type in influenza viruses
timeFrame: Day 0
measure: Number of mutations by type in influenza viruses
timeFrame: Day 7
measure: Number of mutations by type in influenza viruses
timeFrame: Day 14
measure: Number of mutations by type in influenza viruses
timeFrame: Day 21
measure: Number of mutations by type in influenza viruses
timeFrame: Day 28
measure: Biological consequences of mutations in influenza viruses
timeFrame: Day 0
measure: Proportion of mutations in influenza viruses by collection site
timeFrame: Day 7
measure: Proportion of mutations in influenza viruses by collection site
timeFrame: Day 14
measure: Proportion of mutations in influenza viruses by collection site
timeFrame: Day 21
measure: Proportion of mutations in influenza viruses by collection site
timeFrame: Day 28
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Elisabeth E. Adderson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: