Clinical trial NCT06036628: Resistant Bacteria in Children in France
Official title: National Surveillance of the Use of New Antibiotics in Pediatrics and Multi- Resistant Bacteria Involved in Pediatric Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infection Due to Resistant Bacteria
Multi-antibiotic Resistance
Antibiotic Prescription
Risk Factors
Healing
Complications
Intensive Care Unit
Hospital Discharge
Outcome, Fatal
Lead sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2023-09-14
Enrollment: 1000
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatrics patients infected by multi-resistant bacterial, treated by new antibiotics

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relevance of prescribing "new antibiotics" according to patient status
timeFrame: 1 year
measure: Relevance of prescribing "new antibiotics"
timeFrame: 1 year
Secondary outcomes:
measure: Describe Bacterial epidemiology of infections associated with prescription of new antibiotics
timeFrame: 1 year
measure: Identify Risks factors for multi-resistant bacteria
timeFrame: 1 year
measure: Describe Context of drug Prescription
timeFrame: 1 year
measure: Department involved in medical prescribing
timeFrame: 1 year
measure: Describe Associated Antibiotherapies type
timeFrame: 1 year
measure: Describe Associated Antibiotherapies
timeFrame: 1 year
measure: Describe patients outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Créteil
country: France
facility: ACTIV
Study officials:
affiliation: Association Clinique Thérapeutique Infantile du val de Marne
name: Levy Corinne
role: STUDY_DIRECTOR
affiliation: Association Clinique Thérapeutique Infantile du val de Marne
name: Cohen Robert
role: PRINCIPAL_INVESTIGATOR
References: