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

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ClinicalTrials.gov Identifier: NCT02972281

Recruitment Status : Recruiting

First Posted : November 23, 2016

Last Update Posted : May 16, 2018

See Contacts and Locations

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

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	240 participants
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
Estimated Primary Completion Date :	March 2020
Estimated Study Completion Date :	March 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: MDA5 deficiency X-linked immunodeficiency with magnesium defect, Epstein-Barr virus infection, and neoplasia Complement component 8 deficiency Complement factor I deficiency

MedlinePlus related topics: Bacterial Infections

Genetic and Rare Diseases Information Center resources: Bacterial Meningitis Haemophilus Influenzae Primary Agammaglobulinemia

U.S. FDA Resources

Arms and Interventions

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

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 ]

Eligibility Criteria

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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

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

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

Locations

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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

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Principal Investigator:	Guillaume Lefevre, MD	University Hospital, Lille

More Information

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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 Posted:	November 23, 2016 Key Record Dates
Last Update Posted:	May 16, 2018
Last Verified:	May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

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Infection Communicable Diseases Pneumonia Immunologic Deficiency Syndromes Meningitis Otitis Media Pneumococcal Infections Streptococcal Infections Pneumonia, Bacterial Sinusitis Meningitis, Bacterial Chronic Disease 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 Disease Attributes Pathologic Processes

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