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

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ClinicalTrials.gov Identifier: NCT04356053
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date April 17, 2020
First Posted Date April 22, 2020
Last Update Posted Date April 22, 2020
Actual Study Start Date April 1, 2020
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2020)
Immunological abnormalities [ Time Frame: 1 day ]
Immunological abnormalities : based on the screening test
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 17, 2020)
Diagnosis of primary immunodeficiency [ Time Frame: 1 day ]
Diagnosis of primary immunodeficiency
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2020)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Systematic Screening for Primary Immunodeficiencies in Patients Hospitalized for Severe Infections in Intensive Care.
Official Title Systematic Screening for Primary Immunodeficiencies in Patients Hospitalized for Severe Infections in Intensive Care : DIPREA
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).
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pediatric population
Condition Primary Immunodeficiency
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 17, 2020)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 16 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Eric JEZIORSKI 04 67 33 57 98 ext 33 e-jeziorski@chu-montpellier.fr
Contact: Claire LOZANO 04 67 33 67 33 ext 33 c-lozano@chu-montpellier.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04356053
Other Study ID Numbers RECHMPL20_0199
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: NC
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators Not Provided
Investigators
Principal Investigator: Gabrielle VIGUE University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date April 2020