Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
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
Study Start Date : March 2015
Actual Primary Completion Date : March 2020
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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, ...


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Show Show 19 study locations
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
Layout table for investigator information
Principal Investigator: Guillaume Lefevre, MD University Hospital, Lille
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02972281    
Other Study ID Numbers: 2014_07
2014-A00739-38 ( Other Identifier: ID-RCB number, ANSM )
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Pneumococcal Infections
Streptococcal Infections
Pneumonia, Bacterial
Sinusitis
Meningitis, Bacterial
Otitis Media
Meningitis
Primary Immunodeficiency Diseases
Hereditary Complement Deficiency Diseases
Disease Attributes
Pathologic Processes
Pneumonia
Respiratory Tract Infections
 Lung Diseases
Respiratory Tract Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Central Nervous System Diseases
Nervous System Diseases
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Genetic Diseases, Inborn
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Paranasal Sinus Diseases
Nose Diseases