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

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

Study Overview

• Status: Completed
• Conditions: Antibiotic Prescription; Complications; Risk Factors; Outcome, Fatal; Intensive Care Unit; Multi-antibiotic Resistance; Infection Due to Resistant Bacteria; Healing; Hospital Discharge

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 Type: Observational
• Enrollment (Actual): 306

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • ACTIV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

pediatrics patients infected by multi-resistant bacterial, treated by new antibiotics

Description

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
  • 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 Criteria:

• Refusal of participation by the patient or his/her parent
• Medical history of mucoviscidosis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe Bacterial epidemiology of infections associated with prescription of new antibiotics	Characteristic of bacteria associated with prescription of new antibiotics	1 year
Identify Risks factors for multi-resistant bacteria	Type of conditions responsible of multi-resistant such as comorbidities, travel, previous hospitalization, previous antibiotherapy,	1 year
Describe patients outcome	Proportion of patients clinically and bacteriologically recovered	1 year
Describe Context of drug Prescription	How antibiotics medical prescriptions are controlled and validated	1 year
Department involved in medical prescribing	Number of department involved in medical prescriptions	1 year
Describe Associated Antibiotherapies type	Type of drug association prescribed	1 year
Describe Associated Antibiotherapies	Number of drug association prescribed	1 year

Collaborators and Investigators

• Sponsor: Association Clinique Thérapeutique Infantile du val de Marne
• Collaborators: Pfizer
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): December 19, 2025

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: BREF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No