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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02972281
Recruitment Status : Terminated (deficient inclusions)
First Posted : November 23, 2016
Last Update Posted : September 18, 2020
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE November 21, 2016
First Posted Date  ICMJE November 23, 2016
Last Update Posted Date September 18, 2020
Study Start Date  ICMJE March 2015
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria [ Time Frame: At 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2016)
Frequency of PIDs in adult patients whith recurrent and/or severe bactérial infection with encapsulated bacteria [ Time Frame: At 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Systematic Search for Primary Immunodeficiency in Adults With Infections
Official Title  ICMJE Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Complement Deficiency
  • Antibody Deficiency
  • Chronic Sinus Infection
  • Meningitis, Bacterial
  • Pneumonia, Bacterial
  • Otitis Media
  • Streptococcal Infection
  • Neisseria Infections
  • Haemophilus Influenza
  • Pneumococcal Infections
Intervention  ICMJE Biological: Immunological diagnosis tests
(Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ...
Study Arms  ICMJE Patients with bacterial infections
Patients with recurrent and/or severe bacterial infections
Intervention: Biological: Immunological diagnosis tests
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 16, 2020)
120
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2016)
240
Actual Study Completion Date  ICMJE March 2020
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02972281
Other Study ID Numbers  ICMJE 2014_07
2014-A00739-38 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE
  • Imagine Institute
  • Octapharma
  • CSL Behring
  • Laboratoire français de Fractionnement et de Biotechnologies
  • Air Liquide SA
  • The Binding Site Ltd
Investigators  ICMJE
Principal Investigator: Guillaume Lefevre, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP