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Systematic Search for Primary Immunodeficiency in Adults With Infections (SPIDAC)

U

University Hospital, Lille

Status

Terminated

Conditions

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

Treatments

Biological: Immunological diagnosis tests

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02972281
2014-A00739-38 (Other Identifier)
2014_07

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Patients with bacterial infections
Other group
Description:
Patients with recurrent and/or severe bacterial infections
Treatment:
Biological: Immunological diagnosis tests

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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