CClinicalTrials.gg
Status unknownNCT04356053DIPREAUpdated Oct 12, 2021

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

An observational study in Primary Immunodeficiency, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 1 Month to 16 Years. Per ClinicalTrials.gov, last updated 2021-10-12.

Sponsored by University Hospital, Montpellier · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
90
Ages
1 Month to 16 Years
Sex
All
01

Study 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).

Read the 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.

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Conditions studied

  • Primary Immunodeficiency

Keywords

  • severe infection
  • pediatric
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 90 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric population

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
90 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Immunological abnormalities

    Immunological abnormalities : based on the screening test

    Time frame: 1 day

Secondary outcomes

  1. Diagnosis of primary immunodeficiency

    Diagnosis of primary immunodeficiency

    Time frame: 1 day

Other outcomes

  1. duration of hospitalization

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

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Uhmontpellier
    Montpellier, 34295, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04356053
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Apr 22, 2020
Start date
Apr 1, 2020
Primary completion
Dec 1, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Oct 12, 2021

Study contacts

Eric JEZIORSKI
Contact
e-jeziorski@chu-montpellier.fr
04 67 33 57 98 ext. 33
Claire LOZANO
Contact
c-lozano@chu-montpellier.fr
04 67 33 67 33 ext. 33
Gabrielle VIGUE
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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