CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit

Recruiting

• Conditions: Severe Infection; Invasive Bacterial Infection; Hospitalized Children

• Registration Number: NCT06260345
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

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.

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
medical characterisation of children hospitalized for severe communautary bacterial infection case	1 year	Assessment of clinical, biological and microbiological characteristics of hospitalized children in intensive care unit due to severe communautary bacterial infections cases
number of pediatrics cases of severe communautary bacterial infections	1 year	Proportion of hospitalized children in intensive care unit due to severe communautary bacterial infections

Secondary Outcome Measures

Name	Time	Method
Type of complications	1 year	Describe any complications due to infection
Identify predictive signs of severe cases in infected children.	1 year	what are the warning signs of a serious infection?
treatment used during hospitalisation	1 year	type of treatment used during hospitalisation to manage the infection
Bacterial strain characterization	1 year	What bacterial strain is involved in the infection?
Identify risk factors of serious infection	1 year	Describe what is responsible of serious infection
healthcare used for infected children	1 year	Describe healthcare provided during hospitalisation of infected children in order to manage this type of infection
Patients outcome	1 year	Proportion of patients recovered

Trial Locations

Locations (1)

Association Clinique Thérapeutique Infantile du val de Marne; 🇫🇷 Créteil, France