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Resistant Bacteria in Children in France

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06036628
Acronym
BREF
Enrollment
306
Registered
2023-09-14
Start date
2023-04-01
Completion date
2025-12-19
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Association Clinique Thérapeutique Infantile du val de Marne
Lead SponsorOTHER
Pfizer
CollaboratorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Relevance of prescribing "new antibiotics" according to patient status1 yearType 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 yearhow are used new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria

Secondary

MeasureTime frameDescription
Describe Bacterial epidemiology of infections associated with prescription of new antibiotics1 yearCharacteristic of bacteria associated with prescription of new antibiotics
Identify Risks factors for multi-resistant bacteria1 yearType of conditions responsible of multi-resistant such as comorbidities, travel, previous hospitalization, previous antibiotherapy,
Describe Context of drug Prescription1 yearHow antibiotics medical prescriptions are controlled and validated
Department involved in medical prescribing1 yearNumber of department involved in medical prescriptions
Describe Associated Antibiotherapies type1 yearType of drug association prescribed
Describe Associated Antibiotherapies1 yearNumber of drug association prescribed
Describe patients outcome1 yearProportion of patients clinically and bacteriologically recovered

Countries

France

Contacts

STUDY_DIRECTORLevy Corinne

Association Clinique Thérapeutique Infantile du val de Marne

PRINCIPAL_INVESTIGATORCohen Robert

Association Clinique Thérapeutique Infantile du val de Marne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026