跳至主要内容
临床试验/CTRI/2013/01/003333
CTRI/2013/01/003333进行中(未招募)不适用

Registry in the management of acute diarrhea in children: observational study in daily practice.

Sanofi Synthelabo India Limited25 个研究点 分布在 1 个国家目标入组 3,750 人开始时间: 2013年1月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
3,750
试验地点
25
主要终点
To describe the current “real life†management of childhood acute diarrhea in developing countries/regions.

研究概览

简要总结

International, prospective, longitudinal [V1 + 15 daysfollow-up time], observational, non-comparative, multi-center registry inchildren with acute diarrhea. This registry is non-interventional on thetherapeutic strategy.

Study duration per patient: 1 visit, followed by onelongitudinal follow-up visit at 15 (±1) days.

The purpose of the REMAD 2 Registry is to collectinformation about children with acute diarrhea. The goal of this observationalregistry is to evaluate the current clinical practice on the management ofdiarrhea in children.

研究设计

研究类型
Observational

入排标准

年龄范围
6.00 Month(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • •Infants or children presenting with acute diarrhea acquired in the community, • Aged between 6 months to 6 years old, • Children with acute diarrhea evident for less than 48 hours whatever the origin, • Children who had ≥ 3 watery stools during the preceding 24 hours, • Children whose parents or legal guardians have given their written informed consent.

排除标准

  • Children suffering from a chronic disease [Crohn’s Disease, Hemorrhagic rectocolitis, IBS), • Parents or legal guardians unable to fill diary card.
  • • Children suffering from severe malnutrition and/or immuno-compromised.

结局指标

主要结局

To describe the current “real life†management of childhood acute diarrhea in developing countries/regions.

时间窗: At the time of end of the study

次要结局

  • To country/local specificities that may determine some therapeutic decisions /(o Type of center,)

研究者

申办方类型
Pharmaceutical industry-Global

研究点 (25)

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