NCT01072227终止不适用
Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Taiwan
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens
研究概览
简要总结
The purpose of the study is to identify the bacterial aetiology of Acute Otitis Media episodes in young children aged >= 3 months to < 5 years in Taiwan
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: >= 3 months and < 5 years at the time they are seen by the pediatrician or ear, nose and throat specialist. The subject becomes ineligible on the fifth birthday.
- •Onset of signs and symptoms of acute otitis media within 72 hours:
- •One of the functional or general signs of otalgia (, conjunctivitis, fever and either
- •Paradise's criteria or
- •Spontaneous otorrhea of less than 1 day.
- •Written informed consent obtained from parent or legally acceptable representative prior to study start.
排除标准
- •Hospitalized during the diagnosis of acute otitis media.
- •Onset of otorrhea greater than 1 day prior to enrolment.
- •Otitis externa, or otitis media with effusion.
- •Presence of a transtympanic aerator.
- •Systemic antibiotic treatment received for a disease other than acute otitis media in the 72 hours prior to enrolment.
- •Receiving antimicrobial prophylaxis for recurrent acute otitis media.
- •Provision of prescribing antibiotics by ear, nose and throat specialist and Pediatricians for acute otitis media before sample collection.
- •Intended or planned prescription of antibiotic by pediatrician or ear, nose and throat specialist prior to the completion of study specified procedures during the enrolment visit.
结局指标
主要结局
Proportion of H. influenzae, S. pneumoniae and other bacterial pathogens
时间窗: Average duration: 12 months
次要结局
- Distribution of H. influenzae and S. pneumoniae serotypes.(Average duration: 12 months)
- Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis(Average duration: 12 months)
- Occurrence of H. influenzae in AOM cases vaccinated with a pneumococcal vaccine.(Average duration: 12 months)
- Proportion of treatment failure of Acute Otitis Media (AOM) and of recurrent AOM(Average duration: 12 months)
- Occurrence of spontaneous otorrhea(Average duration: 12 months)
- Occurrence of H. influenzae in AOM cases with treatment failure and in new AOM cases without treatment therapy(Average duration: 12 months)
研究者
研究点 (1)
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