Hospitalized ChildrenCAPRICENCT06260345
CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit
An observational study of Hospitalized Children and Severe Infection, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hospitalized Children, Severe Infection, Invasive Bacterial Infection
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children under 18 ages, with severe communautary invasive bacterial infections, hospitalized in pediatric intensive care unit.
Who may be able to join
- 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).
Who cannot join
- Refusal by one of the parents or by Child in understanding age
- Nosocomial infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Association Clinique Thérapeutique Infantile du val de Marne
Créteil, 94600
Corinne Levy, MD, 1 48 85 04 04 ext. +33, corinne.levy@activ-france.fr
Stéphane Béchet, MsC, 1 48 85 04 04 ext. +33, stephane.bechet@activ-france.fr
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
number of pediatrics cases of severe communautary bacterial infections
Proportion of hospitalized children in intensive care unit due to severe communautary bacterial infections
Measured: 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
Measured: 1 year
Secondary outcomes (7)
Identify risk factors of serious infection
Describe what is responsible of serious infection
Measured: 1 year
Identify predictive signs of severe cases in infected children.
what are the warning signs of a serious infection?
Measured: 1 year
healthcare used for infected children
Describe healthcare provided during hospitalisation of infected children in order to manage this type of infection
Measured: 1 year
Type of complications
Describe any complications due to infection
Measured: 1 year
Patients outcome
Proportion of patients recovered
Measured: 1 year
treatment used during hospitalisation
type of treatment used during hospitalisation to manage the infection
Measured: 1 year
Bacterial strain characterization
What bacterial strain is involved in the infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- GFRUP (Groupe Francophone de Réanimation et d'Urgences Pédiatrique), Groupe de Pathologies Infectieuses Pédiatriques (GPIP), 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 staphylocoques, Centre National de Référence des E. Coli
- Responsible party
- Sponsor
- Investigators
- Michael Levy, Principal investigator, CHU Robert Debré, ParisCorinne Levy, Study director, Association Clinique Thérapeutique Infantile du val de Marne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260345
- Sponsor's protocol ID
- CAPRICE
- Acronym
- CAPRICE
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of Pediatric Severe Communautary Bacterial Infections
- ClinicalTrials.gov ID
- NCT06260345
- Acronym / sponsor ID
- CAPRICE / CAPRICE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- GFRUP (Groupe Francophone de Réanimation et d'Urgences Pédiatrique), Groupe de Pathologies Infectieuses Pédiatriques (GPIP), 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 staphylocoques, Centre National de Référence des E. Coli
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children under 18 ages, with severe communautary invasive bacterial infections, hospitalized in pediatric intensive care unit.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Refusal by one of the parents or by Child in understanding age
- Nosocomial infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of pediatrics cases of severe communautary bacterial infections
Time frame: 1 year
Proportion of hospitalized children in intensive care unit due to severe communautary bacterial infections
medical characterisation of children hospitalized for severe communautary bacterial infection case
Time frame: 1 year
Assessment of clinical, biological and microbiological characteristics of hospitalized children in intensive care unit due to severe communautary bacterial infections cases
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Levy principal investigator
CHU Robert Debré, Paris
Corinne Levy study director
Association Clinique Thérapeutique Infantile du val de Marne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalized Children and Severe Infection, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne Levy (1 48 85 04 04 ext. +33, corinne.levy@activ-france.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of pediatrics cases of severe communautary bacterial infections (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.