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NCT Number: NCT04990908

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

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.

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Key information

Age range

3 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Location status: Recruiting

Location contact

Eric Jeziorski, MCU-PH

CONTACT

[email protected]

04 67 33 66 03 ext. 33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion age less than 16 years
  • Inclusion age > 3 months of actual age for term infants and > 3 months for former preterm infants.
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: 1 day

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

Secondary outcomes

  1. Rate of to evaluate the sensitivity of our systematic screening

    Time frame: 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

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)

    Time frame: 1 day

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Eric JEZIORSKI

CONTACT

[email protected]

04 67 33 57 98 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: SPYSI

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2021
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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