Systematic Search for Primary Immunodeficiency in Adults With Infections

Pneumococcal Infections Clinical Trial

— SPIDAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02972281
• Other study ID #: 2014_07
• Secondary ID: 2014-A00739-38
• Status: Terminated
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 2020

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Ch Armentieres	Armentières
France	CH ARRAS	Arras
France	Ch Bethune	Béthune
France	Ch Boulogne-Sur-Mer	Boulogne Sur Mer
France	Ch Cambrai	Cambrai
France	Ch Denain	Denain
France	CH DOUAI	Douai
France	Ch Dunkerque	Dunkerque
France	CH LENS	Lens
France	CHRU,	Lille
France	Hopital Prive La Louviere	Lille
France	Hopital Saint Vincent - Saint Antoine	Lille
France	Ch Arrondissement de Montreuil	Rang-du-Fliers
France	C.H de Roubaix	Roubaix
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

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital, Lille	Air Liquide SA, CSL Behring, Imagine Institute, Laboratoire français de Fractionnement et de Biotechnologies, Octapharma, The Binding Site Ltd

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria		At 6 months