Systematic Search for Primary Immunodeficiency in Adults With Infections

Not Applicable

Terminated

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

• Registration Number: NCT02972281
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-23
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with bacterial infections	Immunological diagnosis tests	Patients with recurrent and/or severe bacterial infections

Primary Outcome Measures

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

Trial Locations

Locations (19)

Ch Armentieres; 🇫🇷 Armentières, France

CH ARRAS; 🇫🇷 Arras, France

Ch Boulogne-Sur-Mer; 🇫🇷 Boulogne Sur Mer, France

Ch Bethune; 🇫🇷 Béthune, France

Ch Cambrai; 🇫🇷 Cambrai, France

Ch Denain; 🇫🇷 Denain, France

CH DOUAI; 🇫🇷 Douai, France

Ch Dunkerque; 🇫🇷 Dunkerque, France

CH LENS; 🇫🇷 Lens, France

Hopital Saint Vincent - Saint Antoine; 🇫🇷 Lille, France

C.H de Roubaix; 🇫🇷 Roubaix, France

Hopital Prive La Louviere; 🇫🇷 Lille, France

CHRU,; 🇫🇷 Lille, France

Ch Arrondissement de Montreuil; 🇫🇷 Rang-du-Fliers, France

Ch Region de St-Omer; 🇫🇷 Saint-Omer, France

Groupe Hospitalier Seclin Carvin; 🇫🇷 Seclin, France

Ch Tourcoing; 🇫🇷 Tourcoing, France

Ch de Valenciennes; 🇫🇷 Valenciennes, France

Clinique Teissier; 🇫🇷 Valenciennes, France