SPIDAC: Systematic Search for Primary Immunodeficiency in Adults With Infections

Sponsor

University Hospital, Lille (Other)

Overall Status

Terminated

CT.gov ID

NCT02972281

Collaborator

Imagine Institute (Other), Octapharma (Industry), CSL Behring (Industry), Laboratoire français de Fractionnement et de Biotechnologies (Industry), Air Liquide SA (Industry), The Binding Site Ltd (Other)

120

Enrollment

Locations

Arm

Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Complement Deficiency Antibody Deficiency Chronic Sinus Infection Meningitis, Bacterial Pneumonia, Bacterial Otitis Media Streptococcal Infection Neisseria Infections Haemophilus Influenza Pneumococcal Infections	Biological: Immunological diagnosis tests	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with bacterial infections Patients with recurrent and/or severe bacterial infections	Biological: Immunological diagnosis tests (Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ...

Arm

Intervention/Treatment

Other: Patients with bacterial infections

Patients with recurrent and/or severe bacterial infections

Biological: Immunological diagnosis tests

(Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ...

Outcome Measures

Primary Outcome Measures

Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria [At 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ch Armentieres	Armentières	France
2	CH ARRAS	Arras	France
3	Ch Boulogne-Sur-Mer	Boulogne Sur Mer	France	62321
4	Ch Bethune	Béthune	France
5	Ch Cambrai	Cambrai	France
6	Ch Denain	Denain	France
7	CH DOUAI	Douai	France
8	Ch Dunkerque	Dunkerque	France
9	CH LENS	Lens	France
10	Hopital Prive La Louviere	Lille	France	59000
11	CHRU,	Lille	France
12	Hopital Saint Vincent - Saint Antoine	Lille	France
13	Ch Arrondissement de Montreuil	Rang-du-Fliers	France
14	C.H de Roubaix	Roubaix	France
15	Ch Region de St-Omer	Saint-Omer	France
16	Groupe Hospitalier Seclin Carvin	Seclin	France
17	Ch Tourcoing	Tourcoing	France
18	Ch de Valenciennes	Valenciennes	France
19	Clinique Teissier	Valenciennes	France