NCT01204385已完成不适用
Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Saudi Arabia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples
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 Saudi Arabia.
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
- •A child will be eligible for inclusion if he/she meets the following criteria:
- •Age: ≥ 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
- •Signs, symptoms, and conditions: i. One of the functional or general signs of otalgia (or its equivalent: irritability), conjunctivitis, fever AND EITHER ii. Paradise's criteria (bulging, diffused or localised inflamed tympanic membranes) OR iii. Spontaneous otorrhoea of less than 24 hours
- •Onset of signs and symptoms of AOM within 72 hours prior to diagnosis of AOM by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 48-72h after initiation of treatment
- •Written informed consent obtained from parent or guardian prior to study start.
排除标准
- •The following criteria should be checked at the time of study entry. If any apply, the child must not be included in the study.
- •Hospitalised during the diagnosis of AOM or during treatment,
- •Otitis externa, or otitis media with effusion
- •Presence of a transtympanic aerator
- •Systemic antibiotic treatment received for a disease other than AOM in the 72 hours prior to enrolment,
- •Receiving antimicrobial prophylaxis for recurrent AOM,
- •Provision of antibiotic by paediatrician/ENT specialist at the enrolment visit, prior to the sampling
- •Patients on antibiotics for AOM who are clinically improving.
结局指标
主要结局
Occurrence of H. influenzae, S. pneumoniae and other bacterial pathogens isolated from middle ear fluid samples
时间窗: Average time frame: 12 months
次要结局
- Occurrence of H. influenzae in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy(Average time frame: 12 months)
- Occurrence of spontaneous otorrhea(Average time frame: 12 months)
- Occurence of H. influenzae and S. pneumoniae serotypes(Average time frame: 12 months)
- Antimicrobial susceptibility of H. influenzae, S. pneumoniae and Moraxella catarrhalis isolated from middle ear fluid samples as assessed by standard microbiological techniques(Average time frame: 12 months)
- Occurrence of H. influenzae in acute otitis media cases vaccinated with a pneumococcal vaccine(Average time frame: 12 months)
- Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media (≥ 3 episodes in the last 6 months or ≥ 4 episodes in 12 months)(Average time frame: 12 months)
研究者
研究点 (1)
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