Systematic Search for Primary Immunodeficiency in Adults With Infections

NCT ID: NCT02972281

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2020-03-31

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.

Conditions

Complement Deficiency; Antibody Deficiency; Chronic Sinus Infection; Meningitis, Bacterial; Pneumonia, Bacterial; Otitis Media; Streptococcal Infection; Neisseria Infections; Haemophilus Influenza; Pneumococcal Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with bacterial infections

Patients with recurrent and/or severe bacterial infections

Group Type: OTHER

Immunological diagnosis tests

Intervention Type: BIOLOGICAL

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

Interventions

Immunological diagnosis tests

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

Intervention Type: BIOLOGICAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imagine Institute

OTHER

Sponsor Role: collaborator

Octapharma

INDUSTRY

Sponsor Role: collaborator

CSL Behring

INDUSTRY

Sponsor Role: collaborator

Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

Sponsor Role: collaborator

Air Liquide SA

INDUSTRY

Sponsor Role: collaborator

The Binding Site Ltd

UNKNOWN

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Lefevre, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Ch Armentieres

Armentières, , France

CH ARRAS

Arras, , France

Ch Bethune

Béthune, , France

Ch Boulogne-Sur-Mer

Boulogne-sur-Mer, , France

Ch Cambrai

Cambrai, , France

Ch Denain

Denain, , France

CH DOUAI

Douai, , France

Ch Dunkerque

Dunkirk, , France

CH LENS

Lens, , France

Hopital Prive La Louviere

Lille, , France

CHRU,

Lille, , France

Hopital Saint Vincent - Saint Antoine

Lille, , France

Ch Arrondissement de Montreuil

Rang-du-Fliers, , France

C.H de Roubaix

Roubaix, , France

Ch Region de St-Omer

Saint-Omer, , France

Groupe Hospitalier Seclin Carvin

Seclin, , France

Ch Tourcoing

Tourcoing, , France

Ch de Valenciennes

Valenciennes, , France

Clinique Teissier

Valenciennes, , France

Countries

France

References

Stabler S, Lamblin C, Gaillard S, Just N, Mihailescu M, Viget N, Sy Ndiaye T, Dzeing Ella A, Brunin G, Weyrich P, Prevotat A, Chenivesse C, Le Rouzic O, Mortuaire G, Vuotto F, Faure K, Leurs A, Wallet F, Loiez C, Titecat M, Le Guern R, Hachulla E, Sanges S, Etienne N, Terriou L, Launay D, Lopez B, Bahuaud M, Batteux F, Dubucquoi S, Gesquiere-Lasselin C, Labalette M, Lefevre G; DIPANOR network. High Frequency of Specific Polysaccharide Antibody Deficiency in Adults With Unexplained, Recurrent and/or Severe Infections With Encapsulated Bacteria. Clin Infect Dis. 2023 Mar 4;76(5):800-808. doi: 10.1093/cid/ciac842.

Reference Type: DERIVED

PMID: 36285530 (View on PubMed)

Other Identifiers

2014-A00739-38

Identifier Type: OTHER

Identifier Source: secondary_id

2014_07

Identifier Type: -

Identifier Source: org_study_id