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Systematic Search for Primary Immunodeficiency in Adults With Infections (SPIDAC)

Primary Purpose

Complement Deficiency, Antibody Deficiency, Chronic Sinus Infection

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Immunological diagnosis tests
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Complement Deficiency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65 yrs old patients
  • ≥ 2 bacterial upper or lower respiratory tract infections/years, for at least 2 years, or
  • ≥ 1 severe bacterial upper or lower respiratory tract infection requiring hospitalization and IV antibiotics, or
  • ≥ 1 invasive infection (meningitis, bacteriemia, arthritis) due to Streptococcus pneumoniae, group A Streptococcus, Haemophilus influenzae, Neisseria meningitidis or Neisseria gonorrhoeae

Exclusion Criteria:

  • concomitant, systemic comorbidity that predisposes to infection (solid or hematological cancer, diabetes mellitus, severe alcohol or intravenous drug abuse, chronic liver or kidney failure, human immunodeficiency virus infection, anatomic or functional asplenia, drug-induced 1 neutropenia, or solid organ or hematopoietic stem cell transplantation).
  • the presence of a local predisposing factor: cigarette smoking (> 5 pack-year and/or 5 cigarettes/day), underlying infection (tuberculosis, influenza…), chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis for pulmonary infections; cerebrospinal leak or preceding upper respiratory tract (URT) infections for non-meningococcal meningitis; oral, dental or skin condition for GAS infections
  • use of corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressants or cytotoxic chemotherapeutics
  • PID diagnosed before the infectious episode in question.
  • current or recent pregnancy
  • hospital-acquired infection (including infections of prostheses).

Sites / Locations

  • Ch Armentieres
  • CH ARRAS
  • Ch Boulogne-Sur-Mer
  • Ch Bethune
  • Ch Cambrai
  • Ch Denain
  • CH DOUAI
  • Ch Dunkerque
  • CH LENS
  • Hopital Prive La Louviere
  • CHRU,
  • Hopital Saint Vincent - Saint Antoine
  • Ch Arrondissement de Montreuil
  • C.H de Roubaix
  • Ch Region de St-Omer
  • Groupe Hospitalier Seclin Carvin
  • Ch Tourcoing
  • Ch de Valenciennes
  • Clinique Teissier

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with bacterial infections

Arm Description

Patients with recurrent and/or severe bacterial infections

Outcomes

Primary Outcome Measures

Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria

Secondary Outcome Measures

Full Information

First Posted
November 21, 2016
Last Updated
September 16, 2020
Sponsor
University Hospital, Lille
Collaborators
Imagine Institute, Octapharma, CSL Behring, Laboratoire français de Fractionnement et de Biotechnologies, Air Liquide SA, The Binding Site Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02972281
Brief Title
Systematic Search for Primary Immunodeficiency in Adults With Infections
Acronym
SPIDAC
Official Title
Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
deficient inclusions
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Imagine Institute, Octapharma, CSL Behring, Laboratoire français de Fractionnement et de Biotechnologies, Air Liquide SA, The Binding Site Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections - especially upper and lower respiratory tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in adults. The current European and US guidelines advocate screening adults for PIDs if they present recurrent benign especially upper and lower respiratory tract infections, or if they have experienced at least two severe bacterial infections and/or have a recurrent need for intravenous antibiotics. The objective of the demonstrate the interest of PIDs screening in adult patients who present such recurrent infections and/or after the first severe bacterial infection, especially when the patients do not present with known, etiologically relevant comorbidities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complement Deficiency, Antibody Deficiency, Chronic Sinus Infection, Meningitis, Bacterial, Pneumonia, Bacterial, Otitis Media, Streptococcal Infection, Neisseria Infections, Haemophilus Influenza, Pneumococcal Infections

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Patients with bacterial infections
Arm Type
Other
Arm Description
Patients with recurrent and/or severe bacterial infections
Intervention Type
Biological
Intervention Name(s)
Immunological diagnosis tests
Intervention Description
(Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ...
Primary Outcome Measure Information:
Title
Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 yrs old patients ≥ 2 bacterial upper or lower respiratory tract infections/years, for at least 2 years, or ≥ 1 severe bacterial upper or lower respiratory tract infection requiring hospitalization and IV antibiotics, or ≥ 1 invasive infection (meningitis, bacteriemia, arthritis) due to Streptococcus pneumoniae, group A Streptococcus, Haemophilus influenzae, Neisseria meningitidis or Neisseria gonorrhoeae Exclusion Criteria: concomitant, systemic comorbidity that predisposes to infection (solid or hematological cancer, diabetes mellitus, severe alcohol or intravenous drug abuse, chronic liver or kidney failure, human immunodeficiency virus infection, anatomic or functional asplenia, drug-induced 1 neutropenia, or solid organ or hematopoietic stem cell transplantation). the presence of a local predisposing factor: cigarette smoking (> 5 pack-year and/or 5 cigarettes/day), underlying infection (tuberculosis, influenza…), chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis for pulmonary infections; cerebrospinal leak or preceding upper respiratory tract (URT) infections for non-meningococcal meningitis; oral, dental or skin condition for GAS infections use of corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressants or cytotoxic chemotherapeutics PID diagnosed before the infectious episode in question. current or recent pregnancy hospital-acquired infection (including infections of prostheses).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Lefevre, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Armentieres
City
Armentières
Country
France
Facility Name
CH ARRAS
City
Arras
Country
France
Facility Name
Ch Boulogne-Sur-Mer
City
Boulogne Sur Mer
ZIP/Postal Code
62321
Country
France
Facility Name
Ch Bethune
City
Béthune
Country
France
Facility Name
Ch Cambrai
City
Cambrai
Country
France
Facility Name
Ch Denain
City
Denain
Country
France
Facility Name
CH DOUAI
City
Douai
Country
France
Facility Name
Ch Dunkerque
City
Dunkerque
Country
France
Facility Name
CH LENS
City
Lens
Country
France
Facility Name
Hopital Prive La Louviere
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHRU,
City
Lille
Country
France
Facility Name
Hopital Saint Vincent - Saint Antoine
City
Lille
Country
France
Facility Name
Ch Arrondissement de Montreuil
City
Rang-du-Fliers
Country
France
Facility Name
C.H de Roubaix
City
Roubaix
Country
France
Facility Name
Ch Region de St-Omer
City
Saint-Omer
Country
France
Facility Name
Groupe Hospitalier Seclin Carvin
City
Seclin
Country
France
Facility Name
Ch Tourcoing
City
Tourcoing
Country
France
Facility Name
Ch de Valenciennes
City
Valenciennes
Country
France
Facility Name
Clinique Teissier
City
Valenciennes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Systematic Search for Primary Immunodeficiency in Adults With Infections

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