Resistant Bacteria in Children in France
BREF
National Surveillance of the Use of New Antibiotics in Pediatrics and Multi- Resistant Bacteria Involved in Pediatric Infections
1 other identifier
observational
306
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 28, 2023
CompletedFirst Posted
Study publicly available on registry
September 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2025
CompletedMarch 19, 2026
March 1, 2026
2.6 years
April 28, 2023
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Relevance of prescribing "new antibiotics" according to patient status
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
1 year
Relevance of prescribing "new antibiotics"
how are used new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria
1 year
Secondary Outcomes (7)
Describe Bacterial epidemiology of infections associated with prescription of new antibiotics
1 year
Identify Risks factors for multi-resistant bacteria
1 year
Describe Context of drug Prescription
1 year
Department involved in medical prescribing
1 year
Describe Associated Antibiotherapies type
1 year
- +2 more secondary outcomes
Eligibility Criteria
pediatrics patients infected by multi-resistant bacterial, treated by new antibiotics
You may qualify if:
- 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
- +15 more criteria
You may not qualify if:
- Refusal of participation by the patient or his/her parent
- Medical history of mucoviscidosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ACTIV
Créteil, 94000, France
Study Officials
- STUDY DIRECTOR
Levy Corinne
Association Clinique Thérapeutique Infantile du val de Marne
- PRINCIPAL INVESTIGATOR
Cohen Robert
Association Clinique Thérapeutique Infantile du val de Marne
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2023
First Posted
September 14, 2023
Study Start
April 1, 2023
Primary Completion
October 31, 2025
Study Completion
December 19, 2025
Last Updated
March 19, 2026
Record last verified: 2026-03