Complement DeficiencySPIDACNCT02972281
Systematic Search for Primary Immunodeficiency in Adults With Infections
A study testing Immunological diagnosis tests in people with Complement Deficiency and Antibody Deficiency, run by University Hospital, Lille at 19 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complement Deficiency, Antibody Deficiency, Chronic Sinus Infection
- What is being tested?
- Immunological diagnosis tests
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 19 sitesFrance
- Study dates
- Mar 2015to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Ch Armentieres
Armentières
CH ARRAS
Arras
Ch Bethune
Béthune
Ch Boulogne-Sur-Mer
Boulogne-sur-Mer, 62321
Ch Cambrai
Cambrai
Ch Denain
Denain
CH DOUAI
Douai
Ch Dunkerque
Dunkirk
CH LENS
Lens
Hopital Prive La Louviere
Lille, 59000
CHRU,
Lille
Hopital Saint Vincent - Saint Antoine
Lille
Ch Arrondissement de Montreuil
Rang-du-Fliers
C.H de Roubaix
Roubaix
Ch Region de St-Omer
Saint-Omer
Groupe Hospitalier Seclin Carvin
Seclin
Ch Tourcoing
Tourcoing
Ch de Valenciennes
Valenciennes
Clinique Teissier
Valenciennes
About this study
Official title: 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.
- Conditions
- Complement Deficiency, Antibody Deficiency, Chronic Sinus Infection, Meningitis, Bacterial, Pneumonia, Bacterial, Otitis Media
- Being tested
- Immunological diagnosis tests
- Medical subject headings
- Hereditary Complement Deficiency Diseases, Meningitis, Bacterial, Pneumonia, Bacterial, Otitis Media, Streptococcal Infections, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunological diagnosis testsBiological
(Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ...
| Study group | Role | What they receive |
|---|---|---|
| Patients with bacterial infections | Other | Patients with recurrent and/or severe bacterial infections Receives: Biological: Immunological diagnosis tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complement DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Imagine Institute, Octapharma, CSL Behring, Laboratoire français de Fractionnement et de Biotechnologies, Air Liquide SA, The Binding Site Ltd
- Responsible party
- Sponsor
- Investigators
- Guillaume Lefevre, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972281
- Sponsor's protocol ID
- 2014_07
- Other IDs
- 2014-A00739-38
- Acronym
- SPIDAC
- Status last verified
- Sep 2020
- First submitted
- 21 Nov 2016
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Stabler S, Lamblin C, Gaillard S, Just N, Mihailescu M, Viget N, Sy Ndiaye T, Dzeing Ella A, Brunin G, Weyrich P, Prevotat A, Chenivesse C, Le Rouzic O, Mortuaire G, Vuotto F, Faure K, Leurs A, Wallet F, Loiez C, Titecat M, Le Guern R, Hachulla E, Sanges S, Etienne N, Terriou L, Launay D, Lopez B, Bahuaud M, Batteux F, Dubucquoi S, Gesquiere-Lasselin C, Labalette M, Lefevre G; DIPANOR network. High Frequency of Specific Polysaccharide Antibody Deficiency in Adults With Unexplained, Recurrent and/or Severe Infections With Encapsulated Bacteria. Clin Infect Dis. 2023 Mar 4;76(5):800-808. doi: 10.1093/cid/ciac842.
PubMed 36285530
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria
- ClinicalTrials.gov ID
- NCT02972281
- Acronym / sponsor ID
- SPIDAC / 2014_07
- Conditions
- Complement Deficiency, Antibody Deficiency, Chronic Sinus Infection, Meningitis, Bacterial, Pneumonia, Bacterial, Otitis Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Imagine Institute, Octapharma, CSL Behring, Laboratoire français de Fractionnement et de Biotechnologies, Air Liquide SA, The Binding Site Ltd
- Study start
- Mar 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bacterial infections | Other | Biological: Immunological diagnosis testsPatients with recurrent and/or severe bacterial infections |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunological diagnosis tests(Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ... | Biological | Patients with bacterial infections |
Primary outcome
Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 36285530Stabler S, Lamblin C, Gaillard S, Just N, Mihailescu M, Viget N, Sy Ndiaye T, Dzeing Ella A, Brunin G, Weyrich P, Prevotat A, Chenivesse C, Le Rouzic O, Mortuaire G, Vuotto F, Faure K, Leurs A, Wallet F, Loiez C, Titecat M, Le Guern R, Hachulla E, Sanges S, Etienne N, Terriou L, Launay D, Lopez B, Bahuaud M, Batteux F, Dubucquoi S, Gesquiere-Lasselin C, Labalette M, Lefevre G; DIPANOR network. High Frequency of Specific Polysaccharide Antibody Deficiency in Adults With Unexplained, Recurrent and/or Severe Infections With Encapsulated Bacteria. Clin Infect Dis. 2023 Mar 4;76(5):800-808. doi: 10.1093/cid/ciac842.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Lefevre, MD principal investigator
University Hospital, Lille
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunological diagnosis tests in people with Complement Deficiency and Antibody Deficiency, run by University Hospital, Lille at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02972281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.