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Pediatric Intensive Care Unit and Primary Immune Deficiency (PICUPID)

Primary Purpose

Immuno-Deficiency

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Systematic screening of immune deficiency
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Immuno-Deficiency

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Caen University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Screening

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 12, 2018
Last Updated
November 28, 2022
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT05629247
Brief Title
Pediatric Intensive Care Unit and Primary Immune Deficiency
Acronym
PICUPID
Official Title
Pediatric Intensive Care Unit and Primary Immune Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
January 26, 2019 (Actual)
Study Completion Date
January 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immuno-Deficiency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screening
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Systematic screening of immune deficiency
Intervention Description
Systematic screening of immune deficiency with blood tests
Primary Outcome Measure Information:
Title
primary immunodeficiencies
Description
to detect primary immunodeficiencies in the course of serious infections or of unfavorable evolution in patients requiring care in the pediatric resuscitation department
Time Frame
change between baseline and 3 month after baseline

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Caen University Hospital
City
Caen
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pediatric Intensive Care Unit and Primary Immune Deficiency

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