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临床试验/NCT00952367
NCT00952367已完成不适用

Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children Aged 12-18 Months in Six Cities of China

Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 3,641 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,641
试验地点
1
主要终点
Percentage of Participants With Serotypes of Streptococcus Pneumoniae

研究概览

简要总结

This study is to observe the carriage rate of Streptococcus pneumoniae (S.p.), Haemophilus influenzae Type B (Hib) and Moraxella catarrhalis (M.Cat.) in healthy Chinese children aged 12-18 months in order to estimate the prevalence of pathogens that commonly cause infection in Chinese young children. The antibiotic resistance of all isolates and the serotypes distribution of S.p. isolates will also be tested. Potential risk factors for nasopharyngeal carriage will be collected.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
12 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage of Participants With Serotypes of Streptococcus Pneumoniae

时间窗: Day 1

Categories are the serotypes of Streptococcus pneumoniae. NO6A/NO6B belongs to Group 6 but is neither 6A nor 6B. NO23F belongs to Group 23 but is not 23F. NO19A/NO19F belongs to Group 19 but is neither 19A nor 19F. Serotypes G, H, D, I, E, F are results of latex agglutination test, and do not refer to a specific serotype; they cannot be further serotyped by the Quellung reaction. NO(Without capsule) includes all Streptococcus pneumoniae isolates that cannot be serotyped because of no capsule.

Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae

时间窗: Day 1

A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.

次要结局

  • Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics(Day 1)
  • Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B(Day 1)
  • Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis(Day 1)
  • Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics(Day 1)
  • Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae(Day 1)
  • Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B(Day 1)
  • Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis(Day 1)
  • Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics(Day 1)

研究者

发起方
Wyeth is now a wholly owned subsidiary of Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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