CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit

Severe Infection Clinical Trial

— CAPRICE  

Official title:

Observatory of Pediatric Severe Communautary Bacterial Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260345
• Other study ID #: CAPRICE
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: January 1, 2030

Study information

• Verified date: January 2024
• Source: Association Clinique Thérapeutique Infantile du val de Marne
• Contact: Corinne Levy
• Phone: 1 48 85 04 04
• Email: corinne.levy[@]activ-france.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Hospitalized Children
• Infections
• Severe Infection

Locations

Country	Name	City	State
France	Association Clinique Thérapeutique Infantile du val de Marne	Créteil

Sponsors (8)

Lead Sponsor	Collaborator
Association Clinique Thérapeutique Infantile du val de Marne	Centre National de Référence des E. Coli, Centre National de Référence des Méningocoques et Haemophilus influenzae, Centre National de Référence des Pneumocoques, Centre National de Référence des staphylocoques, Centre National de Référence des Streptocoques, GFRUP (Groupe Francophone de Réanimation et d'Urgences Pédiatrique), GPIP : Groupe de Pathologies Infectieuses Pédiatriques

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of pediatrics cases of severe communautary bacterial infections	Proportion of hospitalized children in intensive care unit due to severe communautary bacterial infections	1 year
Primary	medical characterisation of children hospitalized for severe communautary bacterial infection case	Assessment of clinical, biological and microbiological characteristics of hospitalized children in intensive care unit due to severe communautary bacterial infections cases	1 year
Secondary	Identify risk factors of serious infection	Describe what is responsible of serious infection	1 year
Secondary	Identify predictive signs of severe cases in infected children.	what are the warning signs of a serious infection?	1 year
Secondary	healthcare used for infected children	Describe healthcare provided during hospitalisation of infected children in order to manage this type of infection	1 year
Secondary	Type of complications	Describe any complications due to infection	1 year
Secondary	Patients outcome	Proportion of patients recovered	1 year
Secondary	treatment used during hospitalisation	type of treatment used during hospitalisation to manage the infection	1 year
Secondary	Bacterial strain characterization	What bacterial strain is involved in the infection?	1 year