Actively Recruiting

Age: 3Months - 16Years
All Genders
ID04990908

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

Led by University Hospital, Montpellier · Updated on 2024-03-29

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Severe infections in children admitted to pediatric intensive care units are common, and there is growing interest in understanding whether genetic factors, such as primary immune deficiencies, contribute to these infections. This observational study aims to determine how often primary immune deficiencies are found in children with severe infections, regardless of the infection type. Researchers want to better understand the role of immune deficiencies in these serious cases. The study will include children aged between 3 months and 16 years who have a documented severe infection requiring hospitalization in pediatric intensive care for more than 24 hours. Eligible infections include those affecting the brain or meninges, lung infections, sepsis-related infections, and encephalitis. Parental or legal guardian consent will be obtained before participation. The study is conducted at University Hospital Centers in Montpellier, Toulouse, and Marseille. Participants will be closely monitored during their hospital stay. Researchers will assess the number of patients diagnosed with primary immune deficiencies after their severe infection. The sensitivity of the systematic screening method will also be evaluated. This study will help identify underlying immune problems in children with severe infections, supporting better diagnosis and care. The study started in September 2023 and is expected to continue until September 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Months - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children younger than 16 years old
  • Children at least 3 months old (corrected age for preterm infants)
  • Documented severe infection requiring hospitalization in pediatric intensive care for more than 24 hours
  • Severe infection may include meninges or brain lesions, lung infections, sepsis, septic shock, encephalitis, or encephalomyelitis
  • Child must be covered by a social security system
  • Parental or legal guardian consent must be obtained
Not Eligible

You will not qualify if you...

  • Severe infections that are not documented
  • Acute bronchiolitis or isolated SRV bronchiolitis without complications
  • Known primary or secondary immune deficiency before the current infection
  • Burns or other comorbidities explaining infection or ICU stay such as epilepsy risk factors, pneumonia from swallowing disorders, chronic lung disease, asthma, cochlear implant-related meningitis, infections related to implanted materials or recent surgery, cardiovascular decompensation, or other chronic conditions contributing to infection
  • Inability to obtain consent from parents or legal guardians

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo systematic screening to identify primary immunodeficiencies after severe infection.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are observed following the diagnostic evaluation to assess outcomes related to primary immunodeficiency.

Follow-up visits as needed

Trial Site Locations

Total: 1 location

1

Uhmontpellier

Montpellier, France, 34295

Actively Recruiting

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Research Team

E

Eric JEZIORSKI

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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