Resistant Bacteria in Children in France

Recruiting

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

• Registration Number: NCT06036628
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

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 is a surveillance study, the clinical and biological characteristics of the children included will be described.

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-04-28
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relevance of prescribing "new antibiotics" according to patient status	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
Relevance of prescribing "new antibiotics"	1 year	how are used new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Créteil, France