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临床试验/NCT02538770
NCT02538770已完成不适用

The Impact of Respiratory Pathogen PCR Assay on Treatment of Adult Patients: A Randomized Controlled Trial

University of Oulu2 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
900
试验地点
2
主要终点
Duration of hospitalization

研究概览

简要总结

Viral respiratory infections are common and often require use of health care resources. Patients receive inappropriate bacterial antibiotics, which has many problems including side-effects, development of resistance and costs.

A small portion of the infections leads to severe clinical manifestations including hospitalisations and deaths. The significance of influenza virus is well known and it is actively detected in all age groups. However, the benefits of detecting other respiratory viruses have mainly been studied among children but not among adults. The development of multiplex PCR technique has provided a new and sensitive method for diagnosing a large panel of viruses. To convince the economical benefits of the rapid viral diagnostic in adult infectious patient, more evidence is needed.

In our randomized study, nasal and pharyngeal samples from the patients evaluated at the emergency clinic of internal medicine in the University Hospital of Oulu because of any respiratory symptom, chest pain or fever, will be collected. The samples will be tested for 16 different respiratory viruses by using Anyplex TMII RV16 Detection. The adult participants will be randomized in two groups. In one group the results of the testing will be reported for the attending physician as soon as possible, and in the other group 7 days after sampling. The effect of this delay to patient care is monitored. Also the results of children and adults are compared as well as results of men and women. The hypothesis is that rapid viral diagnostics shortens the length of admission and diminishes the use of bacterial antibiotics. New information on the viral epidemiology among children and adults is provided and clinical manifestations of specific viral infections in adults are described.

The estimated 1500 samples are also tested for 5 different respiratory bacteria by Anyplex TM II RB5 Detection. These results will be examined after completion of the study period. The benefits of rapid bacterial detection are evaluated in respect to the clinical course of the disease and considering the infection control aspects as well.

详细描述

Aim and Hypothesis

The aim of the study is:

  1. To find out how the modern rapid multiplex-PCR based respiratory virus detection method affects the patient care
  2. To examine does it shorten the length of admission and reduce antibiotic consumption
  3. Compare the seasonality of different viruses in children and adults
  4. Investigate the development and progress of an epidemic
  5. Study the differences in the prevalence and severity of infections between genders
  6. Describe clinical manifestations of different viral infections in adults
  7. View more closely certain subgroups such as patients with chest pain in respect to different viral epidemics and their effect on the hospital admission rates
  8. Evaluate the information provided by the bacterial detection

Subjects Our hospital is both a regional and a university hospital at the same time. Patients come to our clinic from a quite large area surrounding the city of Oulu and they represent the general population of the area well. The study population will be recruited 2014-2015 in the emergency clinics for pediatric and internal medicine patients in the Oulu University Hospital. Participants are patients with respiratory infection symptoms, chest pain or fever. Fever is determined as body temperature of 38 degrees centigrade or more measured either in the hospital or at home.

Study design This is a randomized clinical trial evaluating the impact of modern multiplex PCR based respiratory virus diagnostics on treatment and outcome of adult patients. Participants are randomized in two groups with results being reported either immediately or after a week (Picture 1). In children the viral PCR diagnostics is already routinely used and collection of nasal and pharyngeal samples continues normally. All pediatric results are reported immediately. Approval of the ethical review board of the Northern Ostrobothnia Hospital District has been acquired.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • All patients visiting Oulu University Hospital emergency room or admitted to acute pulmonology ward AND signs of possible respiratory tract infection such as cough, fever or dyspnea OR chest pain

排除标准

  • No exclusion criteria

结局指标

主要结局

Duration of hospitalization

时间窗: One month

The number of days in hospital within one month after randomization

Antimicrobial consumption

时间窗: One month

Number of days on antimicrobials within one month after randomization

次要结局

  • Cost of other examinations in hospital(One month)
  • Number of radiological examinations(One month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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