Resistant Bacteria in Children in France

Intensive Care Unit Clinical Trial

— BREF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036628
• Other study ID #: BREF
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: September 2023
• Source: Association Clinique Thérapeutique Infantile du val de Marne
• Contact: Levy Corinne
• Phone: 1 48 85 04 04
• Email: corinne.levy[@]activ-france.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	ACTIV	Créteil

Sponsors (2)

Lead Sponsor	Collaborator
Association Clinique Thérapeutique Infantile du val de Marne	Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relevance of prescribing "new antibiotics" according to patient status	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	1 year
Primary	Relevance of prescribing "new antibiotics"	how are used new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria	1 year
Secondary	Describe Bacterial epidemiology of infections associated with prescription of new antibiotics	Characteristic of bacteria associated with prescription of new antibiotics	1 year
Secondary	Identify Risks factors for multi-resistant bacteria	Type of conditions responsible of multi-resistant such as comorbidities, travel, previous hospitalization, previous antibiotherapy,	1 year
Secondary	Describe Context of drug Prescription	How antibiotics medical prescriptions are controlled and validated	1 year
Secondary	Department involved in medical prescribing	Number of department involved in medical prescriptions	1 year
Secondary	Describe Associated Antibiotherapies type	Type of drug association prescribed	1 year
Secondary	Describe Associated Antibiotherapies	Number of drug association prescribed	1 year
Secondary	Describe patients outcome	Proportion of patients clinically and bacteriologically recovered	1 year