Children's Antibiotic Resistant Infections in Low Income Countries
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of infections with bacteria resistant to antibiotics in neonates and young children (up to 18 months of age).
研究概览
简要总结
The main challenge of the ChARLI program is to assess the clinical burden of severe neonatal and childhood bacterial infections in low-income countries,in particular those caused by antibiotic resistant bacteria. This program will address both healthcare associated, as well as community acquired infections. Beside its main challenge, the ChARLI program will also allow the assessment of the economic burden of these infections, the improvement of their medical care and then ultimately help to set public health interventions and guide public health measures necessary to combat bacterial infections and bacterial resistance in children. It will also lead to set up more basic research investigation to better understand how pathogenic and epidemic may be the resistant clones in these countries and to experiment innovative strategies devoted to prevent these infections.
In order to achieve these objectives, an international paediatric cohort will be created, and monitored a platform. This will be done first within the Institut Pasteur International Network (IPIN) and possibly extended in some others low income countries where the IPIN has no center. This constituted initiative will represent the first international pediatric program of its size to be located in low-income countries and specifically focusing severe bacterial infections and bacterial resistance to antibiotics
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
- 1 Minute 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonate born to parents living in the study zone of a participating country
- •Parents of the neonate not intending to move away from the study zone during the follow-up period
- •Legal guardians of the neonate informed about the way in which the study is to be carried out and about the collection of biological samples
- •Legal guardians of the neonate having no objection to the collection of biological samples
- •Authorisation from at least one of the legal guardians of the child, in the form of a signed informed consent form.
排除标准
- •Stillborn neonate
- •Parents of the neonate living outside the study zone of a participating country
- •Neonate born to parents planning to move away from the study zone of a participating country during the follow-up period
- •At least one of the legal guardians of the neonate not informed about the study or about the collection of biological samples
- •At least one of the legal guardians of the neonate opposed to the collection of biological samples.
- •Neonate already participating in another biomedical study.
结局指标
主要结局
Incidence of infections with bacteria resistant to antibiotics in neonates and young children (up to 18 months of age).
时间窗: 27 months
次要结局
- Bacterial aetiology of neonatal infection in low income countries and its resistance(27 months)
- Identification of factors responsible of the dissemination and transmission of multiresistant resistant bacteria in low incomes countries(27 months)