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

Recruiting

• Conditions: Severe Infection; Severe Immune Deficiency

• Registration Number: NCT04990908
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-08-05
• Status Verified: 2023-07
• Study Start: 2023-09-04
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2025-09-04
• Study Completion: 2026-09-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit	1 day	number of patients with primary immunodeficiency revealed after a severe infection in pediatric ICU or in neuropediatric unit

Secondary Outcome Measures

Name	Time	Method
Rate of to evaluate the sensitivity of our systematic screening	1 day	To evaluate the sensitivity of our systematic screening in relation to an approach scrupulously following the indications of other published studies for the screening of primary immunodeficiencies

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France