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Recruiting NCT06260345

CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit

— Observational Hospitalized Children Severe Infection Invasive Bacterial Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hospitalized Children, Severe Infection, Invasive Bacterial Infection. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Observatory of Pediatric Severe Communautary Bacterial Infections

Overview

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.

Primary outcome measures

  • number of pediatrics cases of severe communautary bacterial infections [Time frame: 1 year]
  • medical characterisation of children hospitalized for severe communautary bacterial infection case [Time frame: 1 year]
Secondary outcome measures (7)
  • Identify risk factors of serious infection [Time frame: 1 year]
  • Identify predictive signs of severe cases in infected children. [Time frame: 1 year]
  • healthcare used for infected children [Time frame: 1 year]
  • Type of complications [Time frame: 1 year]
  • Patients outcome [Time frame: 1 year]
  • treatment used during hospitalisation [Time frame: 1 year]
  • Bacterial strain characterization [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Association Clinique Thérapeutique Infantile du val de Marne — Créteil

Identifiers

NCT: NCT06260345 · CAPRICE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗