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临床试验/NCT00926198
NCT00926198已完成不适用

Frequency, Pathogen Spectrum and Specific Immune Response in Acute Pharyngotonsillitis in Children and Adolescents

Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 4,500 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,500
试验地点
2
主要终点
The responsible pathogens (Frequency of GABHS) of acute pharyngotonsillitis and its clinical and serological response in children in a large urban setting.

研究概览

简要总结

Acute pharyngotonsillitis is one of the most common infections encountered by pediatricians. Most children with acute pharyngotonsillitis have symptoms that can be attributed to viral infection. However 30-40% of cases is of bacterial etiology.

The purpose of this study is to examine frequency, age distribution, clinical picture and pathogen distribution in acute pharyngotonsillitis in children in a large urban setting.

详细描述

According to the US Vital Health Statistics report, acute pharyngotonsillitis is responsible for more than 6 million office visits each year by children younger than 15 years of age. Approximately 30% of cases is of bacterial etiology and group A beta-hemolytic streptococci(GABHS) are responsible for most bacterial cases, although other pathogens, such as Neisseria gonorrhoeae, Arcanobacterium haemolyticum, Mycoplasma pneumoniae, and Chlamydia pneumoniae, may be the causative agents in sporadic cases. An accurate diagnosis of GABHS infection is important because it is the only common form of acute pharyngotonsillitis for which antibiotic therapy is definitely indicated. Effective antibacterial treatment can shorten the clinical course of GABHS pharyngotonsillitis, reduce the rate of transmission, and prevent suppurative and nonsuppurative complications, such as peritonsillar abscess and acute rheumatic fever.

This study enrolls patients who will present with acute fever and clinical signs of pharyngotonsillitis at three primary pediatric ambulances. A rapid A beta-hemolytic streptococcus (GABHS)-detection test will be performed in these patients. In one office, additional throat cultures are obtained of all patients, and blood is taken in a subgroup of 60 GABHS-positive and 60 GABHS-negative cases. In GABHS-positive patients, a second blood sample will be obtained at day 7th and day 28th, and stored until specific antibody response to GABHS will be measured.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
3 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age 3 months to 18 years
  • clinical signs of tonsillopharyngitis
  • informed consent

排除标准

  • age more than 18 years
  • diagnosed chronic disease or infection (e.x. HIV, tuberculosis, malignancy)
  • current participation in another research projects that may interfere with this study
  • Incapability to perform all study procedure

结局指标

主要结局

The responsible pathogens (Frequency of GABHS) of acute pharyngotonsillitis and its clinical and serological response in children in a large urban setting.

时间窗: 1 year

次要结局

  • In a subset of patients the immune response to GABHS will be measured at beginning and after 7 and 28 days.(one month)

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other

研究点 (2)

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