Systematic Search for Primary Immunodeficiency in Adults With Infections

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.

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Key information

Conditions

Complement Deficiency Antibody Deficiency Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Chronic Sinus Infection Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ear Diseases Genetic Diseases, Inborn Gram-Positive Bacterial Infections Haemophilus Influenza Hereditary Complement Deficiency Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lung Diseases Meningitis Meningitis, Bacterial Neisseria Infections Nervous System Diseases Neuroinflammatory Diseases Otitis Otitis Media Otorhinolaryngologic Diseases Pneumococcal Infections Pneumonia Pneumonia, Bacterial Primary Immunodeficiency Diseases Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infection Streptococcal Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Armentieres, Armentières, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Immunological diagnosis tests

Biological

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

Primary outcomes

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

Time frame: At 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

Air Liquide SA
CSL Behring
Imagine Institute
Laboratoire français de Fractionnement et de Biotechnologies
Octapharma
The Binding Site Ltd

Registry information

Official study title

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

Acronym: SPIDAC

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2020
First posted: Nov 23, 2016
Registry last updated: Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed