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临床试验/NCT01657968
NCT01657968Unknown不适用

Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Procalcitonin

研究概览

简要总结

The primary purpose of the present study is to investigate the usefulness of Procalcitonin as a supplement to the Streptococcal antigen test and Centor criteria in the differential diagnose making between Streptococcal and non-Streptococcal acute tonsillitis.

Furthermore, the investigators aim to examine Procalcitonin as a diagnostic marker in acute tonsillitis due to Fusobacterium Necrophorum.

详细描述

Acute tonsillitis is based on typical symptoms (sore throat, pain on swallowing, and fever) and clinical findings of tonsillar exudate and hyperemia.

10-20% of patients seen by their family physician, have acute tonsillitis due to streptococci group A. In Denmark, Centors criteria and the Streptococcal antigen test (Strep. A-test) are gold standard in the diagnostic process of streptococcal acute tonsillitis. Although the sensitivity and specificity of the Strep. A-test is biochemically high, its clinical reliability is reduced due to several influential factors. Moreover, studies suggest that 4-10% of patients are tested false-negative based on clinical criteria and the Strep A-test.

Fusobacterium necrophorum are suspected to be the cause of acute tonsillitis in teenagers and young adults (5-15%). However, there is no rapid test available for this bacterium. Since tonsillar surface swab is not included in the diagnostic standard, family physicians get no information about infection due to Fusobacterium necrophorum or other pathogens.

C-reactive protein, leukocyte count and absolute neutrophil count as diagnostic markers are examined with variable results. Procalcitonin is a relatively new marker of bacterial infection, which has the advantage of more rapid and specific induction compared to the other markers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
15 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 15 and 40 years.
  • Subjective and objective signs of Acute Tonsillitis + presents of 2-4 Centor Criteria.
  • participation accept after verbal and written information.

排除标准

  • Antibiotic treatment within the last month.
  • Other infection within the last month.
  • Inadequate tonsil swabs due to lack of cooperation.
  • Suspicion of peritonsillar abscess
  • Control patients:
  • Inclusion criteria:
  • Age between 15 and 40 years.
  • Participation accept after verbal and written information.
  • Exclusion Criteria:
  • Antibiotic treatment within the last month.
  • Infection within the last month.
  • Tonsillectomy
  • More than 2 cases of acute tonsillitis within the last 12 months.

结局指标

主要结局

Procalcitonin

时间窗: The participants will bee examined in family practice in 30 minuts, measurement results will be available after 3-4 month (average)

Procalcitonin from all 100 participants will be analyzed at once.

次要结局

  • Centor score(The participants will bee examined in family practice in 30 minuts, measurement results will be available after the consultation)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ann Christensen

Research year student, medical student

Aarhus University Hospital

研究点 (1)

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