Resistant Bacteria in Children in France

NCT ID: NCT06036628

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Association Clinique Thérapeutique Infantile du val de Marne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Levy Corinne

Role: STUDY_DIRECTOR

Association Clinique Thérapeutique Infantile du val de Marne

Cohen Robert

Role: PRINCIPAL_INVESTIGATOR

Association Clinique Thérapeutique Infantile du val de Marne

Locations

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ACTIV

Créteil, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Levy Corinne

Role: CONTACT

1 48 85 04 04 ext. +33

Bechet Stephane

Role: CONTACT

1 48 85 96 68 ext. +33

Facility Contacts

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Corinne Levy, MD

Role: primary

0033148850404

Stéphane Béchet, MSc

Role: backup

0033148850404

Other Identifiers

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BREF

Identifier Type: -

Identifier Source: org_study_id

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