Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit

NCT ID: NCT04990908

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-04

Study Completion Date

2026-09-04

Brief Summary

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Severe infections in pediatric intensive care unit are not uncommon. Historically, the diagnosis of hereditary (primary) immune deficiency required a combination of recurrent clinical signs and biological stigmas. This paradigm is currently being questioned, and grows the hypothesis of a potential underlying genetic susceptibility in any severe infection. To date, the proportion of severe infections explained by an underlying immune deficiency is unknown.

The aim of this prospective study is to assess the incidence of primary immune deficiencies in children with severe infection, regardless of their etiology.

Detailed Description

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Conditions

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Severe Infection Severe Immune Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Inclusion age less than 16 years
* Inclusion age \> 3 months of actual age for term infants and \> 3 months for former preterm infants.
* Documented severe infection (bacterial, viral, fungal) at the University Hospital Center of Montpellier, Toulouse or Marseille
* Severe infections concerned by the study: any infection requiring hospitalization in pediatric intensive care (more than 24 hours) including:
* meninges or brain lesions, pleuro-pneumopathy, any infection associated with sepsis and/or an opportunistic germ, septic shock, etc.
* Encephalitis and encephalomyelitis of infectious origin
* Child benefiting from a social security system
* Collection of parental/legal representative consent

Exclusion Criteria

* Undocumented severe infections
* Acute bronchiolitis
* Children admitted with isolated SRV bronchiolitis without further complications from the infection;
* Previous comorbidity explaining the infection and/or stay in ICU/Continuing Care: Primary or known secondary immune deficiency; burns; risk factors for non-infectious epilepsy (encephalopathy, known epilepsy, head trauma), pneumonia caused by swallowing disorders or tracheotomy or chronic lung disease, asthma, meningitis favored by cochlear implants, breach of blood-brain barrier or neuromeningetic material, deep infection on implanted material or within 48h after surgery, cardiovascular decompensation; any other chronic conditions that may contribute to infection;
* Inability to obtain consent from parents/legal guardians.
Minimum Eligible Age

3 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric JEZIORSKI

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Eric JEZIORSKI

Role: CONTACT

04 67 33 57 98 ext. 33

Facility Contacts

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Eric Jeziorski, MCU-PH

Role: primary

04 67 33 66 03 ext. 33

Other Identifiers

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RECHMPL21_0378

Identifier Type: -

Identifier Source: org_study_id

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