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NCT02352389 · ClinicalTrials.gov registry record
A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 16
- Enrollment target
NCT02352389: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT02352389 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02352389 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 16 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- OTHER Blood sample
- OTHER Stool sample
- OTHER Nasal swab
- OTHER Oropharyngeal swab
- OTHER Symptom checklist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-03-30 |
| Est. Completion | 2022-12-08 |
What the finished NCT02352389 record still lists
NCT02352389 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target.
The record links to 0 conditions, and to 5 interventions - of which Blood sample is the first listed.
NCT02352389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02352389 about?
NCT02352389 is a clinical study titled "A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents". 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...
What is the current status of trial NCT02352389?
This trial is currently completed. The enrollment target is 16 participants. The study started on 2015-03-30. Estimated completion is 2022-12-08.
What interventions are being tested in trial NCT02352389?
The interventions under investigation include: Blood sample (OTHER), Stool sample (OTHER), Nasal swab (OTHER), Oropharyngeal swab (OTHER), Symptom checklist (OTHER).
Who is sponsoring clinical trial NCT02352389?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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