Pediatric Intensive Care Unit and Primary Immune Deficiency (PICUPID)

To date, many studies have focused on the characteristics of PID in children, allowing to highlight an entry into the disease in the context of more or less severe infections in all pediatric departments. However, only one study has so far studied the frequency of these PID in a pediatric resuscitation unit, which is why we propose this study to the Caen University Hospital.

Investigtors propose a two-step study, both retrospective and prospective, in order to increase our cohort.

The retrospective analysis of the data will be done over the period 2013-2016, the prospective analysis will be done from May 2017 to January 2018. The study will be monocentric, performed in the pediatric resuscitation department of the University Hospital of Caen to evaluate the prevalence of PIDs and describe their characteristics.

The included patients will be aged 0 to 18 years, hospitalized in the pediatric intensive care unit for a serious infection and / or of an unfavorable evolution, or an opportunistic germ infection in the absence of a DIP or an immunodeficiency previously known. The inclusion will be proposed by the intensive care pediatricians. Authorization by the legal representative will be required in advance.

The data will be collected during the systematic consultation in pediatric haemato-immuno-oncology within 3 months after their hospitalization in intensive care unit to detect a DIP by a thorough interrogation, a clinical examination and a first-line biological assessment.

A second consultation will be scheduled in the 3 months following the 1st with announcement of the results of the first balance sheet and completion of a second complementary balance sheet if a suspicion of DIP persists at the end of the first balance sheet.

The precise description of the incidence of these immunodeficiencies and their characteristics could lead to the development of recommendations on the routine screening of PID in pediatric resuscitation; an early diagnosis enabling preventive and curative management (vaccine, immunoglobulin, antibiotic prophylaxis, etc.) to be put in place in order to limit the risk of infectious recurrence and reduce the morbidity.

Study Overview

• Status: Completed
• Conditions: Immuno-Deficiency
• Intervention / Treatment: Diagnostic test: Systematic screening of immune deficiency

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Caen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Any child hospitalized in the Pediatric Resuscitation Unit for:

• Severe sepsis or septic shock including those without microbiological documentation or portal of entry found.
• ≥ 1 documented invasive infection with encapsulated germ (Streptococcus pneumoniae, group A streptococcus, Haemophilus influenzae, Neisseria meningitidis).
• An invasive infection with an unusual germ or an opportunistic infection: Bacterial: Salmonella, Tuberculosis, / Fungal: Aspergillosis, Cryptococcosis, Candidiasis / Parasitic: Toxoplasmosis, Pneumocystosis, Giarda lamblia / Viral: enterovirus, CMV, EBV, viral encephalitis

Exclusion Criteria:

• Patient with known primary or secondary immunodeficiency: HIV, known neoplasia, immunosuppressive or immunomodulatory therapy, renal failure, nephrotic syndrome, hypoprotidemia, cirrhosis with hepatic insufficiency, sickle cell disease, splenectomy.
• Local-regional factors that may be responsible for infections: foreign body in the airways, history of ENT surgery or neurosurgery, history of fracture of the skull base, cystic fibrosis, chronic respiratory insufficiency.
• Refusal to sign the consent of the legal representative.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Screening	Diagnostic test: Systematic screening of immune deficiency; Systematic screening of immune deficiency with blood tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary immunodeficiencies	to detect primary immunodeficiencies in the course of serious infections or of unfavorable evolution in patients requiring care in the pediatric resuscitation department	change between baseline and 3 month after baseline

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): January 26, 2019
• Study Completion (Actual): January 26, 2020

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Genetic Diseases, Inborn; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases
• Other Study ID Numbers: 17-158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No