PICUPID: Pediatric Intensive Care Unit and Primary Immune Deficiency

Sponsor

University Hospital, Caen (Other)

Overall Status

Completed

CT.gov ID

NCT05629247

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Immuno-Deficiency	Diagnostic Test: Systematic screening of immune deficiency	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Pediatric Intensive Care Unit and Primary Immune Deficiency

Actual Study Start Date :

Jan 26, 2018

Actual Primary Completion Date :

Jan 26, 2019

Actual Study Completion Date :

Jan 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Screening	Diagnostic Test: Systematic screening of immune deficiency Systematic screening of immune deficiency with blood tests

Arm

Intervention/Treatment

Other: Screening

Diagnostic Test: Systematic screening of immune deficiency

Systematic screening of immune deficiency with blood tests

Outcome Measures

Primary Outcome Measures

primary immunodeficiencies [change between baseline and 3 month after baseline]
to detect primary immunodeficiencies in the course of serious infections or of unfavorable evolution in patients requiring care in the pediatric resuscitation department

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caen University Hospital	Caen		France

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT05629247

Other Study ID Numbers:

17-158

First Posted:

Nov 29, 2022

Last Update Posted:

Nov 29, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Primary Immunodeficiency Diseases

Immunologic Deficiency Syndromes

Study Results

No Results Posted as of Nov 29, 2022