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

This study is currently recruiting participants.
Verified November 2016 by University Hospital, Lille
Sponsor:
ClinicalTrials.gov Identifier:
NCT02972281
First Posted: November 23, 2016
Last Update Posted: November 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Imagine Institute
Octapharma
CSL Behring
Laboratoire français de Fractionnement et de Biotechnologies
Air Liquide SA
The Binding Site Ltd
Information provided by (Responsible Party):
University Hospital, Lille
  Purpose
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.

Condition Intervention
Complement Deficiency Antibody Deficiency Chronic Sinus Infection Meningitis, Bacterial Pneumonia, Bacterial Otitis Media Streptococcal Infection Neisseria Infections Haemophilus Influenza Pneumococcal Infections Biological: Immunological diagnosis tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

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

Estimated Enrollment: 240
Study Start Date: March 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patients with bacterial infections
Patients with recurrent and/or severe bacterial infections
Biological: Immunological diagnosis tests
(Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ...

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972281


Contacts
Contact: Guillaume Lefevre, MD guillaume.lefevre@chru-lille.fr

Locations
France
CHRU, Recruiting
Lille, France
Principal Investigator: Guillaume Lefevre, MD         
Sponsors and Collaborators
University Hospital, Lille
Imagine Institute
Octapharma
CSL Behring
Laboratoire français de Fractionnement et de Biotechnologies
Air Liquide SA
The Binding Site Ltd
Investigators
Principal Investigator: Guillaume Lefevre, MD University Hospital, Lille
  More Information

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02972281     History of Changes
Other Study ID Numbers: 2014_07
2014-A00739-38 ( Other Identifier: ID-RCB number, ANSM )
First Submitted: November 21, 2016
First Posted: November 23, 2016
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Immunologic Deficiency Syndromes
Meningitis
Otitis Media
Pneumococcal Infections
Streptococcal Infections
Pneumonia, Bacterial
Sinusitis
Meningitis, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Immune System Diseases
Central Nervous System Diseases
Nervous System Diseases
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Paranasal Sinus Diseases
Nose Diseases
Central Nervous System Bacterial Infections
Central Nervous System Infections