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

NCT04990908 | Recruiting

• 1 other identifier: RECHMPL21_0378
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Infection; Severe Immune Deficiency

Keywords

genetics; screening

Outcome Measures

Primary Outcomes (1)

• number of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit

  number of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit

  1 day

Secondary Outcomes (1)

• Rate of to evaluate the sensitivity of our systematic screening

  1 day

Other Outcomes (1)

• The number of immune deficiencies that have no other call point based on the list of warning signs of the Reference Center for Hereditary Immune Deficiencies (CEREDIH)

  1 day

Eligibility Criteria

• Age: 3 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric population

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Infections; Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Eric JEZIORSKI

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Eric JEZIORSKI

CONTACT

04 67 33 57 98; e-jeziorski@chu-montpellier.fr

Study Design

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

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: August 5, 2021
• Study Start: September 4, 2023
• Primary Completion: September 4, 2025
• Study Completion (Estimated): September 4, 2026
• Last Updated: March 29, 2024

Record last verified: 2023-07

Locations

FR (1)