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临床试验/NCT00939185
NCT00939185已完成不适用

Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections

Pfizer0 个研究点目标入组 400 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
400
主要终点
Number of Patients With Adverse Events (AEs)

研究概览

简要总结

The objective of this study was to obtain data on the safety, tolerability and compliance with Zithromax in children with bacterial infections of the upper and lower respiratory tract.

详细描述

Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
1 Year 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with respiratory tract infections that received azithromycin according to the approved SPC as this was a non-interventional study.

排除标准

  • According to the approved Summary of Product Characteristics (SPC) for Azithromycin as this was a non interventional study.

研究组 & 干预措施

Azithromycin group

干预措施: Azithromycin (Drug)

结局指标

主要结局

Number of Patients With Adverse Events (AEs)

时间窗: 3 to 7 days after receiving treatment

All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.

次要结局

  • Number of Subjects Who Withdrew From the Study(3 to 7 days after receiving treatment)
  • Compliance(3 to 7 days after receiving treatment)
  • Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital(Day 1)

研究者

发起方
Pfizer
申办方类型
Industry

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