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临床试验/NCT00471770
NCT00471770已完成不适用

Epidemiological Study of Hospitalized Pediatric Pneumonia in China

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 1,000 人开始时间: 2007年2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
1,000
主要终点
The proportion of hospitalized pneumonia cases associated with vaccine-preventable S. Pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).

研究概览

简要总结

To determine the proportion of hospitalized pneumonia cases in children aged 60 months or less associated with vaccine-preventable Streptococcus pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).

详细描述

Subjects meeting the eligibility criteria, including parental informed consent to collect clinical-epidemiological information, will have a deep respiratory aspirate specimen to determine the etiology of the lower respiratory tract infection. Clinicians may obtain other diagnostic specimens, such as pleural fluid, lung tap, cerebrospinal fluid, nasopharyngeal culture, or serum for serological assays, as indicated clinically. The chest radiograph will be taken and read locally according to predetermined criteria and by staff radiologists trained in radiographic criteria for pneumonia. Bacterial isolates other than Streptococcus pneumoniae will be identified according to standardized procedures. S. pneumoniae isolates will be transported to central laboratories for confirmation of identity, serotyping and antibiotic resistance testing, using standard techniques. Serotype will be determined using type-specific sera (Quellung reaction). Antibiotic susceptibility to penicillin, cefuroxime, ceftriaxone, erythromycin, Amoxycillin, Ofloxacin, Vancomycin, and imipenem be conducted using E-test according to standardized procedures at the central facilities.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
— 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age, 60 months or less
  • Meets study criteria for clinical pneumonia
  • All the examination are/can be done within (before or after) 72 hours to enrollment time
  • Informed consent obtained from parent or guardian

排除标准

  • Received any pneumococcal vaccine in the past
  • Current or underlying conditions that would pose a hazard in obtaining the deep respiratory aspirate (e.g., bleeding diathesis, severe respiratory compromise and others as determined by clinician) Aspirates may be obtained from patients who are intubated
  • Any other medical condition that in the opinion of the clinician/investigator would pose a hazard to the child by participating in the study
  • Children with recurrent pneumonia will enter into the study on only one occasion

结局指标

主要结局

The proportion of hospitalized pneumonia cases associated with vaccine-preventable S. Pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).

时间窗: 1 year

次要结局

未报告次要终点

研究者

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

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