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

NCT04356053 | Unknown

• 1 other identifier: RECHMPL20_0199
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Immunodeficiency

Keywords

severe infection; pediatric

Outcome Measures

Primary Outcomes (1)

• Immunological abnormalities

  Immunological abnormalities : based on the screening test

  1 day

Secondary Outcomes (1)

• Diagnosis of primary immunodeficiency

  1 day

Other Outcomes (1)

• duration of hospitalization

  1 day

Eligibility Criteria

• Age: 1 Month - 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Primary Immunodeficiency Diseases; Infections

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Gabrielle VIGUE

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric JEZIORSKI

CONTACT

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

Claire LOZANO

CONTACT

04 67 33 67 33; c-lozano@chu-montpellier.fr

Study Design

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

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 22, 2020
• Study Start: April 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

FR (1)