Status:
UNKNOWN
Resistant Bacteria in Children in France
Lead Sponsor:
Association Clinique Thérapeutique Infantile du val de Marne
Collaborating Sponsors:
Pfizer
Conditions:
Infection Due to Resistant Bacteria
Multi-antibiotic Resistance
Eligibility:
All Genders
Up to 17 years
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 i...
Eligibility Criteria
Inclusion
- 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
- Pleura
- Peritoneum
- Joint fluid
- Other
- 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.
Exclusion
- Refusal of participation by the patient or his/her parent
- Medical history of mucoviscidosis
Key Trial Info
Start Date :
April 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06036628
Start Date
April 1 2023
End Date
March 31 2025
Last Update
February 8 2024
Active Locations (1)
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1
ACTIV
Créteil, France, 94000