Systematic Search for Primary Immunodeficiency in Adults With Infections

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02972281
• Date of registration: 21/11/2016
• Prospective Registration: No
• Primary sponsor: University Hospital, Lille
• Public title: Systematic Search for Primary Immunodeficiency in Adults With Infections SPIDAC
• Scientific title: Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria
• Date of first enrolment: March 2015
• Target sample size: 120
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02972281
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Guillaume Lefevre, MD
• Affiliation: University Hospital, Lille

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Sinus Infection

Haemophilus Influenza

Streptococcal Infection

Neisseria Infections

Antibody Deficiency

Complement Deficiency

Meningitis, Bacterial

Pneumococcal Infections

Pneumonia, Bacterial

Otitis Media

Intervention(s)

Biological: Immunological diagnosis tests

Primary Outcome(s)

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

Secondary ID(s)

2014-A00739-38

2014_07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Laboratoire français de Fractionnement et de Biotechnologies

The Binding Site Ltd

CSL Behring

Air Liquide SA

Imagine Institute

Octapharma