NCT01160055撤回不适用
Identification and Characterisation of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Egypt
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Occurrence of bacterial pathogens isolated from middle ear fluid samples.
研究概览
简要总结
The purpose of this epidemiological study is to identify and characterize the bacteria causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 of enrolment. The subject becomes ineligible on the fifth birthday.
- •Signs, symptoms, and conditions:
- •One of the functional or general signs of otalgia, conjunctivitis, fever AND EITHER
- •Paradise's criteria, OR
- •Spontaneous otorrhoea of less than 1 day.
- •Onset of signs and symptoms of acute otitis media within 3 days prior to diagnosis of acute otitis media by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 2-3 days after initiation of treatment.
- •Written informed consent obtained from parent(s) or Legally Acceptable Representative prior to study start.
排除标准
- •Hospitalised during the diagnosis of acute otitis media or during treatment,
- •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 3 days prior to enrolment,
- •Receiving antimicrobial prophylaxis for recurrent acute otitis media,
- •Provision of antibiotic by the ear nose and throat specialist at the enrolment visit, prior to the sampling of the middle ear fluid by tympanocentesis or spontaneous otorrhoea,
- •Patients on antibiotics for acute otitis media who are clinically improving.
- •Child in care.
结局指标
主要结局
Occurrence of bacterial pathogens isolated from middle ear fluid samples.
时间窗: 12 Months
次要结局
- Occurrence of bacterial serotypes.(12 Months)
- Occurrence of spontaneous otorrhoea.(12 Months)
- Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques.(12 Months)
- Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.(12 Months)
- Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy.(12 Months)
- Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.(12 Months)
研究者
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