CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit (CAPRICE)

Observatory of Pediatric Severe Communautary Bacterial Infections

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Corinne Levy; Phone Number: +33 1 48 85 04 04; Email: corinne.levy@activ-france.fr
• Study Contact Backup: Name: stéphane Béchet; Phone Number: +33 1 48 85 04 04; Email: stephane.bechet@activ-france.fr

Study Locations

• France
  • Créteil, France, 94600
    • Recruiting
    • Association Clinique Thérapeutique Infantile du val de Marne
    • Contact: Corinne Levy, MD; Phone Number: +33 1 48 85 04 04; Email: corinne.levy@activ-france.fr
    • Contact: Stéphane Béchet, MsC; Phone Number: +33 1 48 85 04 04; Email: stephane.bechet@activ-france.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children under 18 ages, with severe communautary invasive bacterial infections, hospitalized in pediatric intensive care unit.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Association Clinique Thérapeutique Infantile du val de Marne
• Collaborators: Centre National de Référence des staphylocoques; GFRUP (Groupe Francophone de Réanimation et d'Urgences Pédiatrique); Centre National de Référence des Streptocoques; Centre National de Référence des Pneumocoques; Centre National de Référence des Méningocoques et Haemophilus influenzae; Centre National de Référence des E. Coli; Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
• Investigators: Study Director: Corinne Levy, Association Clinique Thérapeutique Infantile du val de Marne; Principal Investigator: Michael Levy, CHU Robert Debré, Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections
• Other Study ID Numbers: CAPRICE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No