DIPREA: Systematic Screening for Primary Immunodeficiencies in Patients Hospitalized for Severe Infections in Intensive Care.

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04356053
Collaborator
(none)
90
1
21
4.3

Study Details

Study Description

Brief Summary

Currently about 90 cases of infection in children are reported every year in pediatric intensive care, a disease considered to be the main cause of hospitalization of children. 16% of invasive pneumococcal infections are linked to a genetic abnormality in immunity. Herpetic encephalitis has become a model of genetic infectious disease, with new mutations identified in the TLR3 pathway. Severe infections are no longer the result of chance and can be the way to reveal a primary immune deficiency. In this context, the investigators propose to evaluate the incidence of hereditary immune deficiency after a systematic immunological screening in children admitted for a severe infection in pediatric intensive care unit (ICU).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Severe infection requiring admission in intensive care unit (ICU) are not so rare. A retrospective pilot study conducted at Montpellier University Hospital Center (UHC) between 2013 and 2015 showed that 19.7% of the pediatric ICU admissions were related to a severe infection. An isolated severe infectious episode could be related to a hereditary immune deficiency (HID), even though there are no history of recurrent clinical signs and biological stigmata. For example, Gaschignard and colleagues considered that 16% of the invasive pneumococcal infections are related to a genetic defect of immunity (doi: 10.1093/cid/ciu274). Growing evidence has shown that severe infectious diseases occurring in childhood are attributed to inborn errors of immunity (doi: 10.1073/pnas.1521651112). While the nosology of severe infections has strong links to inherited immune deficiency that are rare diseases affecting less than 1 birth / 5000, there are no prospective studies that assessed the incidence of primary immune deficiencies in children who presented a severe infection.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Systematic Screening for Primary Immunodeficiencies in Patients Hospitalized for Severe Infections in Intensive Care : DIPREA
    Actual Study Start Date :
    Apr 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Immunological abnormalities [1 day]

      Immunological abnormalities : based on the screening test

    Secondary Outcome Measures

    1. Diagnosis of primary immunodeficiency [1 day]

      Diagnosis of primary immunodeficiency

    Other Outcome Measures

    1. duration of hospitalization [1 day]

      Compare the duration of hospitalization enter the group treated by alone antibiotic and the group treated by antibiotic and surgical drainage.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Subject aged 1 month to 16 years.

    • Admission in pediatric ICU for more than 24h.

    • Documented severe infection (bacterial, viral, fungal).

    • Child benefiting from a social security scheme.

    • Collection of parental consent / legal representatives.

    Exclusion criteria:
    • Prematurity (gestational age <37 weeks of gestation) up to 6 months of age.

    • Undocumented severe infections.

    • Children entered for isolated RSV bronchiolitis, with no other infectious related complications.

    • Previous comorbidity explaining the infection and/or the stay in intensive care / continuous care: known primary or secondary immunodeficiency; burned; risk factors for status epilepticus (encephalopathy, known epilepsy, head trauma), pneumonia or asthma (swallowing disorders, tracheotomy, chronic pulmonary pathology, asthma), meningitis (cochlear implants, breccia, neuromeningeal material), deep infection (implanted material, recent surgery), cardiovascular decompensation.

    • Any other chronic pathology favoring an infection

    • Impossibility to obtain the consent of parents / legal representatives.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Gabrielle VIGUE, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04356053
    Other Study ID Numbers:
    • RECHMPL20_0199
    First Posted:
    Apr 22, 2020
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2021