跳至主要内容
临床试验/NCT06260371
NCT06260371招募中不适用

National Observatory of Mycoplasma Infections in Hospitalized Children Under 18 Ages in France

Association Clinique Thérapeutique Infantile du val de Marne1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年9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
3,000
试验地点
1
主要终点
Number of patients hospitalized for mycoplasma infections

研究概览

简要总结

This study was set up because of an unusual increase in the number of cases of mycoplasma infections in France between June and November 2023.

Clinical data from children with mycoplasma infections will be collected to characterise this infection and facilitate hospital management.

详细描述

In this study, the number of cases will be collected. In addition, we will determine the clinical, biological and microbiological characteristics of these cases.

These following data will be collected: signs or symptoms associated with this infection, clinical complications, biological and microbiological tests done during hospitalisation, treatment used during hospitalization, results of thoracic x-ray and lung ultrasound.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
1 Day 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age <18 years (only hospitalized children)
  • Documented mycoplasma infection (positive multiplex PCR and/or positive serology)

排除标准

  • Refusal by one of the parents or by Child in understanding age

结局指标

主要结局

Number of patients hospitalized for mycoplasma infections

时间窗: 1 year

Proportion of hospitalized children due to mycoplasma infections

medical characterisation of mycoplasma infections

时间窗: 1 year

Assessment of clinical, biological and microbiological characteristics of mycoplasma infections cases.

次要结局

  • Identify predictive signs of serious infection(1 year)
  • Patients outcome(1 year)
  • healthcare used for infected children(1 year)
  • clinical description of infected children(1 year)
  • Type of mycoplasma involved in infected children(1 year)
  • Identify risk factors of serious infection(1 year)
  • performance of complementary diagnostic tests for lung disorders(1 year)
  • Type of complications(1 year)
  • treatment used during hospitalisation(1 year)
  • compare medical data collected during hospitalisation(1 year)

研究者

发起方
Association Clinique Thérapeutique Infantile du val de Marne
申办方类型
Other
责任方
Sponsor

研究点 (1)

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