NCT01031082已完成不适用
Identification and Characterization of the Bacteria Causing Acute Otitis Media (AOM) Episodes in HIV-positive and HIV-negative Children in South Africa
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Occurrence of bacterial pathogens isolated from middle ear fluid samples in HIV-positive and HIV-negative subjects.
研究概览
简要总结
The purpose of this study is to identify and characterize the bacteria causing acute otitis media episode in HIV-positive and HIV-negative children (>=3 months to <5 years) in South Africa. Middle ear fluid sampling either by tympanocentesis or by careful sampling of spontaneous otorrhoea will be done; nasopharyngeal aspirate and urine sample will also be collected from the subjects.
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
- •Inclusion criteria for all subjects:
- •Age: >= 3 months and < 5 years at the time of enrolment.
- •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 24 hours.
- •Subject will be included as a treatment failure case.
- •Written informed consent obtained from parent or guardian prior to study start.
- •Inclusion criteria for HIV-positive subjects:
- •Documented HIV-positive status as given in subject's medical records. or
- •Subjects referred from paediatric HIV clinic.
- •Inclusion criteria for HIV-negative subjects (including presumed negative children)
- •Children who have been tested HIV-negative.
- •Children whose mothers volunteer to have tested HIV-negative whilst pregnant with the index case and the child is free to any World Health Organization Grade II stigmata of HIV/acquired immunodeficiency syndrome.
- •Children who do not fulfil the World Health Organization staging for HIV infection / immunosuppression.
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 72 hours prior to enrolment.
- •Receiving antimicrobial prophylaxis for recurrent acute otitis media but excluding cotrimoxazole or isoniazid prophylaxis in HIV exposed children.
- •Provision of antibiotic by paediatrician/ENT specialist at the enrolment visit prior to the sampling of the middle ear fluid or spontaneous Otorrhoea.
- •Children on antibiotics for acute otitis media who are clinically improving.
结局指标
主要结局
Occurrence of bacterial pathogens isolated from middle ear fluid samples in HIV-positive and HIV-negative subjects.
次要结局
- Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.
- Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.
- Occurrence of spontaneous otorrhoea.
- Occurrence of bacteria in acute otitis media cases with treatment failure and in new acute otitis media cases without treatment therapy.
- Occurrence of bacterial serotypes.
- Antimicrobial susceptibility of different bacteria isolated from middle ear fluid samples as assessed by standard microbiological techniques.
- Frequency of concurrent respiratory viral infection coinciding with the episode of acute otitis media.
- The comparison of above endpoints in HIV-positive and HIV-negative subjects.
研究者
研究点 (1)
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