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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04356053
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Information provided by (Responsible Party):
University Hospital, Montpellier

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
Primary Immunodeficiency

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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Study Type : Observational
Estimated 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 : April 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 30, 2021

Primary Outcome Measures :
  1. Immunological abnormalities [ Time Frame: 1 day ]
    Immunological abnormalities : based on the screening test

Secondary Outcome Measures :
  1. Diagnosis of primary immunodeficiency [ Time Frame: 1 day ]
    Diagnosis of primary immunodeficiency

Other Outcome Measures:
  1. duration of hospitalization [ Time Frame: 1 day ]
    Compare the duration of hospitalization enter the group treated by alone antibiotic and the group treated by antibiotic and surgical drainage.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04356053

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Contact: Eric JEZIORSKI 04 67 33 57 98 ext 33
Contact: Claire LOZANO 04 67 33 67 33 ext 33

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Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: Gabrielle VIGUE, Doctor    04 67 33 67 33 ext 33      
Contact: claire LOZANO, Doctor    04 67 33 67 33 ext 33   
Sponsors and Collaborators
University Hospital, Montpellier
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Principal Investigator: Gabrielle VIGUE University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier Identifier: NCT04356053    
Other Study ID Numbers: RECHMPL20_0199
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
severe infection
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases