Systematic Search for Primary Immunodeficiency in Adults With Infections (SPIDAC)
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ClinicalTrials.gov Identifier: NCT02972281 |
Recruitment Status :
Terminated
(deficient inclusions)
First Posted : November 23, 2016
Last Update Posted : September 18, 2020
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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 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 |

Arm | Intervention/treatment |
---|---|
Patients with bacterial infections
Patients with recurrent and/or severe bacterial infections
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Biological: Immunological diagnosis tests
(Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ... |
- Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria [ Time Frame: At 6 months ]

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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 |
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).

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

Principal Investigator: | Guillaume Lefevre, MD | University Hospital, Lille |
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 |
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 |