National Surveillance of the Use of New Antibiotics in Pediatrics and Multi- Resistant Bacteria Involved in Pediatric Infections
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Relevance of prescribing "new antibiotics"
Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Refusal of participation by the patient or his/her parent
- •Medical history of mucoviscidosis
Outcomes
Primary Outcomes
Relevance of prescribing "new antibiotics"
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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)