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临床试验/NCT05270291
NCT05270291招募中不适用

Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis in the Absence of Diarrhea

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
198
试验地点
1
主要终点
The proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.

研究概览

简要总结

In children with acute gastroenteritis (AGE), vomiting often precedes diarrhea. To establish the diagnosis of AGE, enteropathogen detection typically relies on diarrheal stool samples. However, testing requires sufficient stool sample, which may not be easily available. Recent studies suggest that in children presenting to emergency departments with presumed AGE with isolated vomiting, an enteropathogen can be identified using rectal swabs and molecular diagnostic tests. The rate of enteropathogen detection in children with isolated vomiting due to AGE may differ in various populations. Using rectal swabs and molecular diagnostic tests, we plan to assess the proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.

This will be a prospective cohort study. Children younger than 5 years with presence of ≥3 episodes of vomiting due to presumed AGE, lasting no longer than 7 days before enrolment, will be recruited. A total of 198 participants will be recruited and a rectal swab will be collected. The participants will be contacted 14 days after enrollment to complete a survey regarding symptoms experienced during that period and to identify any additional clinical care.

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 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age 0-5-year-old
  • presence of ≥3 episodes of vomiting due to presumed AGE at inclusion
  • <7 days of symptoms at the time of inclusion
  • signed written informed consent

排除标准

  • anticipated inability to complete 14 days follow-up
  • history of neutropenia (as rectal swabs are contraindicated)
  • critically ill status requiring urgent medical intervention
  • inability to provide a rectal swab for testing
  • chronic gastrointestinal tract disorders such as inflammatory bowel disease, cystic fibrosis, coeliac disease
  • immunodeficiency

结局指标

主要结局

The proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.

时间窗: immediately after the procedure

次要结局

  • Types of pathogens detected based on presenting symptoms(immediately after the procedure)
  • The proportion of children with isolated vomiting with alternative diagnosis(immediately after procedure)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hanna Szajewska

Profesor

Medical University of Warsaw

研究点 (1)

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