Resistant Bacteria in Children in France (BREF)

Association Clinique Thérapeutique Infantile du val de Marne

Status: Enrolling

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06036628

BREF

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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