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Systematic Search for Primary Immunodeficiency in Adults With Infections

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02972281
Acronym
SPIDAC
Enrollment
120
Registered
2016-11-23
Start date
2015-03-01
Completion date
2020-03-01
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BIOLOGICALImmunological diagnosis tests

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER
Imagine Institute
CollaboratorOTHER
Octapharma
CollaboratorINDUSTRY
CSL Behring
CollaboratorINDUSTRY
Laboratoire français de Fractionnement et de Biotechnologies
CollaboratorINDUSTRY
Air Liquide SA
CollaboratorINDUSTRY
The Binding Site Ltd
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteriaAt 6 months

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGuillaume Lefevre, MD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026