National Surveillance of the Use of New Antibiotics in Pediatrics and Multi- Resistant Bacteria Involved in Pediatric Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Relevance of prescribing "new antibiotics"
研究概览
简要总结
This study is observational, multicenter and prospective study for surveillance of the use of new antibiotics in pediatrics for treated pediatrics infections due to multi-resistant bacteria
详细描述
The main of this study is to evaluate the relevance of prescribing "new antibiotics" according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation
As this is a surveillance study, the clinical and biological characteristics of the children included will be described.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under 18 years of age
- •Hospitalized in France in a hospital center working with the ACTIV/GPIP network
- •Treated with one or more of the following antibiotics:
- •Colimycin (Colistimethate sodium)
- •Cefiderocol
- •Aztreonam in combination
- •Ceftolozane-Tazobactam
- •Ceftazidime-avibactam
- •Meropenem/vaborbactam
- •Imipenem/Relebactam
- •Tigecycline
- •Daptomycin
- •Ceftaroline fosamil
- •Tedizolid phosphate
- •Fidaxomicin
- •Ceftobiprole
- •Dalbavancin
- •In association with a documented infection performed by:
- •Blood culture
- •Normally sterile site
- •Cerebrospinal fluid
- •Pleural fluid
- •Peritoneum
- •Joint fluid
- •Urine sampling if the bacteria was considered responsible for the infection (associated with a leukocyturia ≥10,0000)
- •Respiratory specimens if the bacteria was considered responsible for the infection
- •Sampling on material such as:Intubation probe, Orthopedic, Urological, Central Nervous System (CNS),....
- •Related to colonization with multidrug-resistant bacteria without documentation.
排除标准
- •Refusal of participation by the patient or his/her parent
- •Medical history of mucoviscidosis
结局指标
主要结局
Relevance of prescribing "new antibiotics"
时间窗: 1 year
how are used new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria
Relevance of prescribing "new antibiotics" according to patient status
时间窗: 1 year
Type of new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation
次要结局
- Describe Bacterial epidemiology of infections associated with prescription of new antibiotics(1 year)
- Describe Associated Antibiotherapies(1 year)
- Describe Associated Antibiotherapies type(1 year)
- Describe Context of drug Prescription(1 year)
- Identify Risks factors for multi-resistant bacteria(1 year)
- Department involved in medical prescribing(1 year)
- Describe patients outcome(1 year)