Clinical trial NCT02972281: Systematic Search for Primary Immunodeficiency in Adults With Infections
Official title: Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Complement Deficiency
Antibody Deficiency
Chronic Sinus Infection
Meningitis, Bacterial
Pneumonia, Bacterial
Otitis Media
Streptococcal Infection
Neisseria Infections
Haemophilus Influenza
Pneumococcal Infections
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Imagine Institute
name: Octapharma
name: CSL Behring
name: Laboratoire français de Fractionnement et de Biotechnologies
name: Air Liquide SA
name: The Binding Site Ltd
First posted: 2016-11-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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).

Primary outcomes:
measure: Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Armentières
country: France
facility: Ch Armentieres
city: Arras
country: France
facility: CH ARRAS
city: Boulogne Sur Mer
country: France
facility: Ch Boulogne-Sur-Mer
city: Béthune
country: France
facility: Ch Bethune
city: Cambrai
country: France
facility: Ch Cambrai
city: Denain
country: France
facility: Ch Denain
city: Douai
country: France
facility: CH DOUAI
city: Dunkerque
country: France
facility: Ch Dunkerque
city: Lens
country: France
facility: CH LENS
city: Lille
country: France
facility: Hopital Prive La Louviere
city: Lille
country: France
facility: CHRU,
city: Lille
country: France
facility: Hopital Saint Vincent - Saint Antoine
city: Rang-du-Fliers
country: France
facility: Ch Arrondissement de Montreuil
city: Roubaix
country: France
facility: C.H de Roubaix
city: Saint-Omer
country: France
facility: Ch Region de St-Omer
city: Seclin
country: France
facility: Groupe Hospitalier Seclin Carvin
city: Tourcoing
country: France
facility: Ch Tourcoing
city: Valenciennes
country: France
facility: Ch de Valenciennes
city: Valenciennes
country: France
facility: Clinique Teissier
Study officials:
affiliation: University Hospital, Lille
name: Guillaume Lefevre, MD
role: PRINCIPAL_INVESTIGATOR
References: