- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02972281
Systematic Search for Primary Immunodeficiency in Adults With Infections (SPIDAC)
September 16, 2020 updated by: University Hospital, Lille
Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Armentières, France
- Ch Armentieres
-
Arras, France
- CH Arras
-
Boulogne Sur Mer, France, 62321
- CH Boulogne-sur-Mer
-
Béthune, France
- CH Bethune
-
Cambrai, France
- Ch Cambrai
-
Denain, France
- Ch Denain
-
Douai, France
- CH DOUAI
-
Dunkerque, France
- Ch Dunkerque
-
Lens, France
- CH LENS
-
Lille, France, 59000
- Hôpital Privé La Louvière
-
Lille, France
- CHRU,
-
Lille, France
- Hopital Saint Vincent - Saint Antoine
-
Rang-du-Fliers, France
- Ch Arrondissement de Montreuil
-
Roubaix, France
- C.H de Roubaix
-
Saint-Omer, France
- Ch Region de St-Omer
-
Seclin, France
- Groupe Hospitalier Seclin Carvin
-
Tourcoing, France
- Ch Tourcoing
-
Valenciennes, France
- CH de Valenciennes
-
Valenciennes, France
- Clinique Teissier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients with bacterial infections
Patients with recurrent and/or severe bacterial infections
|
(Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ...
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria
Time Frame: At 6 months
|
At 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Guillaume Lefevre, MD, University Hospital, Lille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
November 21, 2016
First Submitted That Met QC Criteria
November 21, 2016
First Posted (Estimate)
November 23, 2016
Study Record Updates
Last Update Posted (Actual)
September 18, 2020
Last Update Submitted That Met QC Criteria
September 16, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Pneumonia
- Lung Diseases
- Disease Attributes
- Genetic Diseases, Inborn
- Otorhinolaryngologic Diseases
- Central Nervous System Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Ear Diseases
- Paranasal Sinus Diseases
- Nose Diseases
- Otitis
- Central Nervous System Bacterial Infections
- Infections
- Communicable Diseases
- Pneumococcal Infections
- Sinusitis
- Primary Immunodeficiency Diseases
- Meningitis
- Otitis Media
- Pneumonia, Bacterial
- Streptococcal Infections
- Meningitis, Bacterial
- Hereditary Complement Deficiency Diseases
Other Study ID Numbers
- 2014_07
- 2014-A00739-38 (Other Identifier: ID-RCB number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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