Clinical trial NCT06260345: CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit
Official title: Observatory of Pediatric Severe Communautary Bacterial Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hospitalized Children
Severe Infection
Invasive Bacterial Infection
Lead sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Sponsor class: OTHER
Collaborators: name: GFRUP (Groupe Francophone de Réanimation et d'Urgences Pédiatrique)
name: Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
name: Centre National de Référence des Streptocoques
name: Centre National de Référence des Pneumocoques
name: Centre National de Référence des Méningocoques et Haemophilus influenzae
name: Centre National de Référence des staphylocoques
name: Centre National de Référence des E. Coli
First posted: 2024-02-15
Enrollment: 3000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 18 ages, with severe communautary invasive bacterial infections, hospitalized in pediatric intensive care unit.

Brief summary: Severe bacterial infections are a worldwide scourge. However, the epidemiology of this type of infection varies over time. It is therefore essential to monitor them in order to prevent them more effectively. At this time, in France, no monitoring exists for this kind of infections.

Detailed description: The main aim of this study is to assess the number of cases and describe the clinical, biological and microbiological characteristics of these cases of severe communautary invasive bacterial infections in children hospitalized in pediatric intensive care units. In addition, the management of these hospitalized children will be described.

Eligibility criteria: Inclusion Criteria:

* Age \<18 years (only hospitalized children)
* Severe communautary bacterial infection defined by hospitalization in a pediatric intensive care unit (documentation of infection by identification of the bacteria in a sterile environment).

Exclusion Criteria:

* Refusal by one of the parents or by Child in understanding age
* Nosocomial infection

Primary outcomes:
measure: number of pediatrics cases of severe communautary bacterial infections
timeFrame: 1 year
measure: medical characterisation of children hospitalized for severe communautary bacterial infection case
timeFrame: 1 year
Secondary outcomes:
measure: Identify risk factors of serious infection
timeFrame: 1 year
measure: Identify predictive signs of severe cases in infected children.
timeFrame: 1 year
measure: healthcare used for infected children
timeFrame: 1 year
measure: Type of complications
timeFrame: 1 year
measure: Patients outcome
timeFrame: 1 year
measure: treatment used during hospitalisation
timeFrame: 1 year
measure: Bacterial strain characterization
timeFrame: 1 year
Other outcomes:
Locations:
city: Créteil
country: France
facility: Association Clinique Thérapeutique Infantile du val de Marne
Study officials:
affiliation: CHU Robert Debré, Paris
name: Michael Levy
role: PRINCIPAL_INVESTIGATOR
affiliation: Association Clinique Thérapeutique Infantile du val de Marne
name: Corinne Levy
role: STUDY_DIRECTOR
References: