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OpenTrials
Completed

NCT Number: NCT06036628

Resistant Bacteria in Children in France

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

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ACTIV

Créteil, 94000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Relevance of prescribing "new antibiotics"

    Time frame: 1 year

    how are used new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria

Secondary outcomes

  1. Describe Bacterial epidemiology of infections associated with prescription of new antibiotics

    Time frame: 1 year

    Characteristic of bacteria associated with prescription of new antibiotics

  2. Identify Risks factors for multi-resistant bacteria

    Time frame: 1 year

    Type of conditions responsible of multi-resistant such as comorbidities, travel, previous hospitalization, previous antibiotherapy,

  3. Describe Context of drug Prescription

    Time frame: 1 year

    How antibiotics medical prescriptions are controlled and validated

  4. Department involved in medical prescribing

    Time frame: 1 year

    Number of department involved in medical prescriptions

  5. Describe Associated Antibiotherapies type

    Time frame: 1 year

    Type of drug association prescribed

  6. Describe Associated Antibiotherapies

    Time frame: 1 year

    Number of drug association prescribed

  7. Describe patients outcome

    Time frame: 1 year

    Proportion of patients clinically and bacteriologically recovered

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Collaborators

  • Pfizer

Registry information

Official study title

National Surveillance of the Use of New Antibiotics in Pediatrics and Multi- Resistant Bacteria Involved in Pediatric Infections

Acronym: BREF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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