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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections; Pneumonia, Bacterial; Meningitis, Bacterial; Otitis Media; Chronic Sinus Infection; Streptococcal Infection; Antibody Deficiency; Complement Deficiency; Neisseria Infections; Haemophilus Influenza
• Intervention / Treatment: Biological: Immunological diagnosis tests

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Armentières, France
    • Ch Armentieres
  • Arras, France
    • CH Arras
  • Boulogne-sur-Mer, France, 62321
    • Ch Boulogne-Sur-Mer
  • Béthune, France
    • CH Béthune
  • Cambrai, France
    • Ch Cambrai
  • Denain, France
    • Ch Denain
  • Douai, France
    • CH DOUAI
  • Dunkirk, France
    • CH Dunkerque
  • Lens, France
    • CH Lens
  • Lille, France, 59000
    • Hôpital Privé La Louvière
  • Lille, France
    • CHRU,
  • Lille, France
    • Hopital Saint Vincent - Saint Antoine
  • Rang-du-Fliers, France
    • Ch Arrondissement de Montreuil
  • Roubaix, France
    • C.H de Roubaix
  • Saint-Omer, France
    • Ch Region de St-Omer
  • Seclin, France
    • Groupe Hospitalier Seclin Carvin
  • Tourcoing, France
    • CH Tourcoing
  • Valenciennes, France
    • CH de Valenciennes
  • Valenciennes, France
    • Clinique Teissier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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, ...

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria	At 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: CSL Behring; Laboratoire français de Fractionnement et de Biotechnologies; Octapharma; Air Liquide SA; Imagine Institute; The Binding Site Ltd
• Investigators: Principal Investigator: Guillaume Lefevre, MD, University Hospital, Lille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimated): November 23, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Primary Immunodeficiency Diseases; Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Immunologic Deficiency Syndromes; Pneumonia; Otorhinolaryngologic Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Ear Diseases; Otitis; Central Nervous System Infections; Meningitis; Central Nervous System Bacterial Infections; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hereditary Complement Deficiency Diseases; Pneumococcal Infections; Pneumonia, Bacterial; Streptococcal Infections; Otitis Media; Meningitis, Bacterial; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques; Immunologic Tests
• Other Study ID Numbers: 2014_07; 2014-A00739-38 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED