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临床试验/NCT02352389
NCT02352389已完成不适用

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

St. Jude Children's Research Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Proportion of patients with oropharyngeal shedding of influenza viruses

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Proportion of patients with oropharyngeal shedding of influenza viruses

时间窗: 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.

Proportion of patients with nasal shedding of influenza viruses

时间窗: 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.

次要结局

  • Frequency of gastrointestinal shedding of human influenza virus(Day 28)
  • Proportion of mutations in influenza viruses by collection site(Day 28)
  • Biological consequences of mutations in influenza viruses(Day 0)
  • Number of mutations by type in influenza viruses(Day 28)
  • Frequency of mutations in influenza viruses(Day 28)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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