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

NCT02352389 | Completed

• 1 other identifier: FLUMUT
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human

Keywords

Childhood; Cancer; Genetic mutations

Outcome Measures

Primary Outcomes (10)

• Proportion of patients with nasal shedding of influenza viruses

  Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with nasal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

  Day 0

• Proportion of patients with nasal shedding of influenza viruses

  Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with nasal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

  Day 7

• Proportion of patients with nasal shedding of influenza viruses

  Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with nasal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

  Day 14

• Proportion of patients with nasal shedding of influenza viruses

  Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with nasal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

  Day 21

• Proportion of patients with nasal shedding of influenza viruses

  Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with nasal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

  Day 28

• Proportion of patients with oropharyngeal shedding of influenza viruses

  Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with oropharyngeal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

  Day 0

• Proportion of patients with oropharyngeal shedding of influenza viruses

  Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with oropharyngeal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

  Day 7

• Proportion of patients with oropharyngeal shedding of influenza viruses

  Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with oropharyngeal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

  Day 14

• Proportion of patients with oropharyngeal shedding of influenza viruses

  Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with oropharyngeal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

  Day 21

• Proportion of patients with oropharyngeal shedding of influenza viruses

  Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with oropharyngeal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

  Day 28

Secondary Outcomes (20)

• Frequency of gastrointestinal shedding of human influenza virus

  Day 0

• Frequency of gastrointestinal shedding of human influenza virus

  Day 7

• Frequency of gastrointestinal shedding of human influenza virus

  Day 14

• Frequency of gastrointestinal shedding of human influenza virus

  Day 21

• Frequency of gastrointestinal shedding of human influenza virus

  Day 28

Study Arms (1)

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.

Other: Blood sample; Other: Nasal swab; Other: Oropharyngeal swab; Other: Stool sample; Other: Symptom checklist

Interventions

Blood sample OTHER

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

Also known as: Blood work

Influenza

Nasal swab OTHER

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

Also known as: Mid-turbinate swab

Influenza

Oropharyngeal swab OTHER

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

Also known as: Throat swab

Influenza

Stool sample OTHER

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

Also known as: Stool specimen

Influenza

Symptom checklist OTHER

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

Also known as: History

Influenza

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Influenza, Human; Neoplasms

Interventions

Blood Specimen Collection; Health Records, Personal

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Medical Records; Records; Data Collection; Epidemiologic Methods

Study Officials

• Elisabeth E. Adderson, MD, MSc

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 2, 2015
• Study Start: March 30, 2015
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

US (1)