Influenza, HumanNCT02352389
A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents
An observational study of Influenza, Human, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Blood sample, Nasal swab and Oropharyngeal swab
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2015to 8 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Influenza, Human
- Being tested
- Blood sample, Nasal swab, Oropharyngeal swab, Stool sample, Symptom checklist
- Keywords
- Childhood, Cancer, Genetic mutations
- Medical subject headings
- Influenza, Human, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Also called Blood work
Blood samples will be drawn and analyzed at Day 0, 7, 14, 21, and 28
Nasal swabOther
Also called Mid-turbinate swab
Obtained on Day 0, 7, 14, 21 and 28.
Oropharyngeal swabOther
Also called Throat swab
Obtained on Day 0, 7, 14, 21 and 28.
Stool sampleOther
Also called Stool specimen
Obtained on Day 0, 7, 14, 21 and 28.
Symptom checklistOther
Also called History
Obtained on Day 0, 7, 14, 21 and 28.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood sample; Other: Nasal swab; Other: Oropharyngeal swab; Other: Stool sample; Other: Symptom checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 28
Secondary outcomes (20)
Frequency of gastrointestinal shedding of human influenza virus
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of gastrointestinal shedding of human influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided. Frequency of gastrointestinal shedding of human influenza virus and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.
Measured: Day 0
Frequency of gastrointestinal shedding of human influenza virus
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of gastrointestinal shedding of human influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided. Frequency of gastrointestinal shedding of human influenza virus and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.
Measured: Day 7
Frequency of gastrointestinal shedding of human influenza virus
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of gastrointestinal shedding of human influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided. Frequency of gastrointestinal shedding of human influenza virus and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.
Measured: Day 14
Frequency of gastrointestinal shedding of human influenza virus
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of gastrointestinal shedding of human influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided. Frequency of gastrointestinal shedding of human influenza virus and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.
Measured: Day 21
Frequency of gastrointestinal shedding of human influenza virus
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of gastrointestinal shedding of human influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided. Frequency of gastrointestinal shedding of human influenza virus and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.
Measured: Day 28
Frequency of mutations in influenza viruses
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of human influenza viruses with mutations and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.
Measured: Day 0
Frequency of mutations in influenza viruses
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of human influenza viruses with mutations and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.
Measured: Day 7
Frequency of mutations in influenza viruses
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of human influenza viruses with mutations and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.
Measured: Day 14
Frequency of mutations in influenza viruses
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of human influenza viruses with mutations and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.
Measured: Day 21
Frequency of mutations in influenza viruses
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of human influenza viruses with mutations and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.
Measured: Day 28
Number of mutations by type in influenza viruses
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the type of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days will be provided to show the pattern of mutations. Genetic variants are defined to meet a minimum minor allele frequency of 20%.
Measured: Day 0
Number of mutations by type in influenza viruses
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the type of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days will be provided to show the pattern of mutations. Genetic variants are defined to meet a minimum minor allele frequency of 20%.
Measured: Day 7
Number of mutations by type in influenza viruses
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the type of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days will be provided to show the pattern of mutations. Genetic variants are defined to meet a minimum minor allele frequency of 20%.
Measured: Day 14
Number of mutations by type in influenza viruses
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the type of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days will be provided to show the pattern of mutations. Genetic variants are defined to meet a minimum minor allele frequency of 20%.
Measured: Day 21
Number of mutations by type in influenza viruses
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the type of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days will be provided to show the pattern of mutations. Genetic variants are defined to meet a minimum minor allele frequency of 20%.
Measured: Day 28
Biological consequences of mutations in influenza viruses
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days that are associated with antiviral resistance will be provided to show the biological consequences. Two-sample t-tests or Wilcoxon rank-sum tests will be performed as appropriate to compare isolates to parental influenza isolates from the same patients.
Measured: Day 0
Proportion of mutations in influenza viruses by collection site
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days that are associated with antiviral resistance will be provided to show the biological consequences. Two-sample t-tests or Wilcoxon rank-sum tests will be performed as appropriate to compare isolates to parental influenza isolates from the same patients.
Measured: Day 7
Proportion of mutations in influenza viruses by collection site
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days that are associated with antiviral resistance will be provided to show the biological consequences. Two-sample t-tests or Wilcoxon rank-sum tests will be performed as appropriate to compare isolates to parental influenza isolates from the same patients.
Measured: Day 14
Proportion of mutations in influenza viruses by collection site
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days that are associated with antiviral resistance will be provided to show the biological consequences. Two-sample t-tests or Wilcoxon rank-sum tests will be performed as appropriate to compare isolates to parental influenza isolates from the same patients.
Measured: Day 21
Proportion of mutations in influenza viruses by collection site
Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days that are associated with antiviral resistance will be provided to show the biological consequences. Two-sample t-tests or Wilcoxon rank-sum tests will be performed as appropriate to compare isolates to parental influenza isolates from the same patients.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study start30 Mar 2015
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth E. Adderson, MD, MSc, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352389
- Sponsor's protocol ID
- FLUMUT
- Status last verified
- Dec 2023
- First submitted
- 22 Jan 2015
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents
- ClinicalTrials.gov ID
- NCT02352389
- Acronym / sponsor ID
- FLUMUT
- Conditions
- Influenza, Human
- Keywords
- Childhood, Cancer, Genetic mutations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 30 Mar 2015 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza | – | Other: Blood sample, Other: Nasal swab, Other: Oropharyngeal swab, Other: Stool sample, Other: Symptom checklistChildren 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. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleAlso: Blood workBlood samples will be drawn and analyzed at Day 0, 7, 14, 21, and 28 | Other | Influenza |
| Nasal swabAlso: Mid-turbinate swabObtained on Day 0, 7, 14, 21 and 28. | Other | Influenza |
| Oropharyngeal swabAlso: Throat swabObtained on Day 0, 7, 14, 21 and 28. | Other | Influenza |
| Stool sampleAlso: Stool specimenObtained on Day 0, 7, 14, 21 and 28. | Other | Influenza |
| Symptom checklistAlso: HistoryObtained on Day 0, 7, 14, 21 and 28. | Other | Influenza |
Primary outcome
Proportion of patients with nasal shedding of influenza viruses
Time frame: Day 0
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.
Proportion of patients with nasal shedding of influenza viruses
Time frame: Day 7
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.
Proportion of patients with nasal shedding of influenza viruses
Time frame: Day 14
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.
Proportion of patients with nasal shedding of influenza viruses
Time frame: Day 21
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.
Proportion of patients with nasal shedding of influenza viruses
Time frame: Day 28
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.
Proportion of patients with oropharyngeal shedding of influenza viruses
Time frame: Day 0
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.
Proportion of patients with oropharyngeal shedding of influenza viruses
Time frame: Day 7
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.
Proportion of patients with oropharyngeal shedding of influenza viruses
Time frame: Day 14
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.
Proportion of patients with oropharyngeal shedding of influenza viruses
Time frame: Day 21
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.
Proportion of patients with oropharyngeal shedding of influenza viruses
Time frame: Day 28
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.
20 secondary outcomes
Frequency of gastrointestinal shedding of human influenza virus
Time frame: Day 0
Frequency of gastrointestinal shedding of human influenza virus
Time frame: Day 7
Frequency of gastrointestinal shedding of human influenza virus
Time frame: Day 14
Frequency of gastrointestinal shedding of human influenza virus
Time frame: Day 21
Frequency of gastrointestinal shedding of human influenza virus
Time frame: Day 28
Frequency of mutations in influenza viruses
Time frame: Day 0
Frequency of mutations in influenza viruses
Time frame: Day 7
Frequency of mutations in influenza viruses
Time frame: Day 14
Frequency of mutations in influenza viruses
Time frame: Day 21
Frequency of mutations in influenza viruses
Time frame: Day 28
Number of mutations by type in influenza viruses
Time frame: Day 0
Number of mutations by type in influenza viruses
Time frame: Day 7
Number of mutations by type in influenza viruses
Time frame: Day 14
Number of mutations by type in influenza viruses
Time frame: Day 21
Number of mutations by type in influenza viruses
Time frame: Day 28
Biological consequences of mutations in influenza viruses
Time frame: Day 0
Proportion of mutations in influenza viruses by collection site
Time frame: Day 7
Proportion of mutations in influenza viruses by collection site
Time frame: Day 14
Proportion of mutations in influenza viruses by collection site
Time frame: Day 21
Proportion of mutations in influenza viruses by collection site
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth E. Adderson, MD, MSc principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, Human, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with nasal shedding of influenza viruses (time frame: Day 0). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.