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临床试验/NCT03064620
NCT03064620Unknown不适用

PICR-b Nasopharyngeal S. Pneumoniae and Nasal S. Aureus Carriage Study

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 12,800 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
12,800
试验地点
1
主要终点
S. pneumoniae carriage

研究概览

简要总结

Objective: PCV effects on S. pneumoniae and S. aureus carriage in a population based study. The major specific aims:

  1. To compare different PCV vaccination policies, by cross-sectional repeated surveillance of closely related populations living in regions with different vaccination policies.
  2. To compare the epidemiology, predictors and outcomes of antibiotic resistant S. aureus and S. pneumoniae in different regions of the PICR.

Study design: Annual / Biannual cross-sectional surveillance of nasal S. aureus carriage and nasopharyngeal S. pneumoniae carriage in children and one of their parents.

详细描述

Study design: Annual / Biannual cross-sectional surveillance of nasal S. aureus carriage and nasopharyngeal S. pneumoniae carriage in children and one of their parents.

PICR districts: 1. Palestinian Authority (PA) - particularly: Bethlehem, Ramallah and Nabulus. 2. East Jerusalem (EJ) 3. Central Israel (IL) - particularly: Rishon Lezion, Bat Yam, Holon 4. Gaza strip (GZ) - 12 regions including cities/villages in central/northern Gaza.

Study population:

Child (age 0-5y) & Parent who attend clinics (for any reason).

Exclusion criteria:

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Any child younger than 5 years, visiting the participating clinics during the surveillance period

排除标准

  • Older than 5 years
  • Previously participated in the study.
  • Sibling has participated in the study.
  • Parent does not agree to sign informed consent

结局指标

主要结局

S. pneumoniae carriage

时间窗: 1 Day

S. pneumoniae carriage of children and parents by the different groups

次要结局

  • S. aureus carriage(1 Day)
  • Carriage of antibiotic resistant S. pneumonia(1 Day)
  • Carriage of MRSA(1 Day)
  • Carriage of Vaccine-type S. pneumoniae(1 Day)
  • Carriage of piliated S. pneumonia(1 Day)

研究者

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

Gili Regev-Yochay MD

Head of Infect Dis Epi Section, Gertner

Sheba Medical Center

研究点 (1)

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