Systematic Search for Primary Immunodeficiency in Adults With Infections

NCT02972281 | Completed

• 2 other identifiers: 2014_072014-A00739-38
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 19

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

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

Outcome Measures

Primary Outcomes (1)

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

  At 6 months

Study Arms (1)

Patients with bacterial infections

OTHER

Patients with recurrent and/or severe bacterial infections

Biological: Immunological diagnosis tests

Interventions

Immunological diagnosis tests BIOLOGICAL

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

Patients with bacterial infections

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Lille: lead
• Imagine Institute: collaborator
• Octapharma: collaborator
• CSL Behring: collaborator
• Laboratoire français de Fractionnement et de Biotechnologies: collaborator
• Air Liquide SA: collaborator
• The Binding Site Ltd: collaborator

Study Sites (19)

Ch Armentieres

Armentières, France

Location

CH ARRAS

Arras, France

Location

Ch Bethune

Béthune, France

Location

Ch Boulogne-Sur-Mer

Boulogne-sur-Mer, 62321, France

Location

Ch Cambrai

Cambrai, France

Location

Ch Denain

Denain, France

Location

CH DOUAI

Douai, France

Location

Ch Dunkerque

Dunkirk, France

Location

CH LENS

Lens, France

Location

Hopital Prive La Louviere

Lille, 59000, France

Location

CHRU,

Lille, France

Location

Hopital Saint Vincent - Saint Antoine

Lille, France

Location

Ch Arrondissement de Montreuil

Rang-du-Fliers, France

Location

C.H de Roubaix

Roubaix, France

Location

Ch Region de St-Omer

Saint-Omer, France

Location

Groupe Hospitalier Seclin Carvin

Seclin, France

Location

Ch Tourcoing

Tourcoing, France

Location

Ch de Valenciennes

Valenciennes, France

Location

Clinique Teissier

Valenciennes, France

Location

Related Publications (1)

• 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.

  PMID: 36285530 RESULT

MeSH Terms

Conditions

Hereditary Complement Deficiency Diseases; Meningitis, Bacterial; Pneumonia, Bacterial; Otitis Media; Streptococcal Infections; Pneumococcal Infections

Interventions

Immunologic Tests

Condition Hierarchy (Ancestors)

Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Gram-Positive Bacterial Infections

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Guillaume Lefevre, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 23, 2016
• Study Start: March 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 21, 2026

Record last verified: 2020-09

Locations

FR (19)