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临床试验/NCT03265730
NCT03265730Unknown不适用

Incidence, Risk Factors and Severity of Pediatric Antibiotic Associated Diarrhea

Hacettepe University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
Incidence of Antibiotic Associated Diarrhea (AAD) in Children in Turkey

研究概览

简要总结

Diarrhea is one of the side effects of antibiotics. Antibiotic associated diarrhea can be encountered between two hours to two months after starting of antibiotics. The purpose of the study is to determine incidence,risk factors and severity of pediatric antibiotic associated diarrhea in Turkey.

详细描述

Antibiotic associated diarrhea is a common adverse effect, occurring about 5-30% of patients either early during treatment or up to two months after the cessation of the treatment. The frequency differs according to the definition of diarrhea, the inciting antimicrobial agent and the host factors such geriatric age, immunosuppression, prolonged hospitalization. Almost all agents, especially the the ones acting on anaerobes may cause diarrhea. Clinical presentations range from mild diarrhea to fulminant pseudomembranous enterocolitis. In Turkey still data about antibiotic associated diarrhea is not enough. Incidence and the factors that effect severity are not known.

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
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The parents and the child who give consent
  • The children who are treated for the acute infections in the outpatient clinics and whole treatment is completed in the outpatient clinics.
  • Children who are born mature, for the children who are younger than 1 year of age.

排除标准

  • The parents and child who do not give consent
  • Children who have primary and secondary immunosuppressive states.
  • Children who had abdominal/gastrointestinal tract surgery in the past.
  • Children who had used probiotics/prebiotics in the last one month period.
  • Children who had used antibiotics in the last one month period.
  • Children who has accompanying gastrointestinal symptoms.
  • Children who are using anti-acid treatment at the time of involvement.

结局指标

主要结局

Incidence of Antibiotic Associated Diarrhea (AAD) in Children in Turkey

时间窗: December 2018

How common the antibiotic associated diarrhea is encountered in pediatric age group in outpatient clinic in Turkey.

次要结局

  • Follow-up of Severity of AAD in Outpatient Clinics and by Phone Calls for Two Months Period in Pediatric Population in Turkey.(December 2018)
  • Incidence of antibiotic associated diarrhea in different age groups(December 2018)
  • Incidence of antibiotic associated diarrhea with different type and formulation of antibiotic(December 2018)
  • Local differences in pediatric AAD across Turkey(December 2018)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ates Kara

Prof Dr

Hacettepe University

研究点 (1)

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