CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit

NCT06260345 | Recruiting DMC

• 1 other identifier: CAPRICE
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Infection; Invasive Bacterial Infection; Hospitalized Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Identify risk factors of serious infection

  1 year

• Identify predictive signs of severe cases in infected children.

  1 year

• healthcare used for infected children

  1 year

• Type of complications

  1 year

• Patients outcome

  1 year

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Association Clinique Thérapeutique Infantile du val de Marne

Créteil, 94600, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

samples (blood, pleura, trachea, skine, urine, cerebrospinal fluid etc...) taken during routine care are stored and analysed later for strain characterization by several national reference centers, including those for streptococci, staphylococci, pneumococci, meningococci, hemophilus and Escherichia Coli.

MeSH Terms

Conditions

Infections

Study Officials

• Michael Levy

  CHU Robert Debré, Paris

  PRINCIPAL INVESTIGATOR

• Corinne Levy

  Association Clinique Thérapeutique Infantile du val de Marne

  STUDY DIRECTOR

Central Study Contacts

Corinne Levy

CONTACT

1 48 85 04 04; corinne.levy@activ-france.fr

stéphane Béchet

CONTACT

1 48 85 04 04; stephane.bechet@activ-france.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (1)