Specific Antibody DeficiencyDETECTNCT05664035
Frequency of SPAD in Adult Patients
An observational study of Specific Antibody Deficiency and Predominantly Antibody Deficiencies, run by University Hospital, Lille at 1 site in France.
Trial summary
The DETECT study aims to demonstrate the importance of detecting SPAD in adult patients with recurrent benign and/or severe unexplained bacterial upper/lower respiratory tract infections. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Specific Antibody Deficiency, Predominantly Antibody Deficiencies
- What is being tested?
- Diagnosis of SPAD using immunization with PPV23
- Type of treatment
- Vaccines
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients seen in Pneumology, Immunology, ENT or Infectious Diseases departments
Who may be able to join
- 18 to 65 year old patients
- With a history of recurrent bacterial infections of upper and/or lower respiratory tract for at least 2 years, and fulfilling the specific following criteria:
- Recurrent benign infections currently requiring 6 courses of antibiotics /year or more, or Bilateral bronchiectasis/bronchiolitis (after exclusion of cystic fibrosis and ciliary dyskinesia) AND recurrent benign infections currently requiring 3 courses of antibiotics /year or more or A history of severe upper/lower respiratory tract bacterial infection, and/or invasive infection with Streptococcus pneumonia, Streptococcus pyogenes or Haemophilus influenzae, which required hospitalization in the last 2 years, AND recurrent benign infections currently requiring 3 courses of antibiotics /year.
- Normal serum IgG, IgA, IgM and IgG subclasses levels, normal CH50 and serum complement C3 and C4 proteins levels, normal T cells count
- Normal B cell count, normal serum protein electrophoresis and immunofixation. (* excepted for Pseudomonas aeruginosa colonization)
Who cannot join
- Any general condition that predisposes to infections: solid or hematological malignancies, 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;
- Any local predisposing factor to infections: cigarette smoking (> 10 pack-year and/or 5 cigarettes/day), underlying infection (tuberculosis, influenza…), chronic obstructive pulmonary disease, oral, dental or skin conditions favorizing infections, streptococcal skin infections
- Any other SID or PID diagnosed before inclusion
- Pregnancy
- PPV23 administration in the last 2 years (risk of hyporesponsiveness)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Lille University Hospital
Lille, 59037
GUILLAUME LEFEVRE, MD, PhD
About this study
Official title: Detection of Specific Polysaccharide Antibody Deficiency in Adult Patients With Unexplained Recurrent and/or Severe Bacterial Infections
The DETECT study aims to demonstrate the importance of detecting SPAD in adult patients with recurrent benign and/or severe unexplained bacterial upper/lower respiratory tract infections. Unlike children in whom the deficit may be transient, long-term strategies are warranted in SPAD adult patients to prevent severe infections and lung disability. Beyond the diagnosis of this still unrecognized PID in adult patients, the investigators want to assess the impact of prophylactic antibiotics or IgRT on infections prevention and on quality of life in adult patients with the most severe clinical phenotypes, recurrent infections with high frequency of antibiotics take and/or recurrent infections with complications like bronchiectasis and/or severe infections requiring hospitalizations.
Read the detailed description
This multicenter observational prospective study will be conducted in 15 university or general hospitals, mostly centers included in the national network of the reference center CEREDIH. Pulmonologists, clinical immunologists and ENT specialists will be solicited in each center to refer patients for inclusions.
All patients who fulfill eligibility criteria will be tested for anti-pneumococcal polysaccharides (PnPSs) response with the 23-valent pneumococcal (unconjugated) vaccine (PPV23) (V1, Day 0: blood sample anti-PnPS antibodies, and immunization; V2, Day 28-56): blood sample for anti-PnPS antibodies).
If a SPAD would be diagnosed, the investigator will be free to consider prophylactic antibiotics and/or IgRT according to the medical history of the patient (notably in case of persistent infections while using prophylactic antibiotics). The efficiency on infections prevention and the impact on health-related quality of life (HRQoL) will be assessed 12 months after initiation of IgRT or prophylactic antibiotics (Visit 3).
- Being tested
- Diagnosis of SPAD using immunization with PPV23
- Keywords
- Specific Antibody Deficiency, Predominant antibody deficiencies, Ig replacement therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of SPAD using immunization with PPV23Biological
Diagnosis of SPAD using immunization with PPV23
| Study group | Role | What they receive |
|---|---|---|
| Case group | 18 to 65 year old patients with a history of recurrent bacterial infections of upper and/or lower respiratory tract for at least 2 years Receives: Biological: Diagnosis of SPAD using immunization with PPV23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the frequency of SPAD in adult patients with unexplained recurrent bacterial respiratory infections
Diagnosis of SPAD according to the AAAAI proposed consensus criteria for an impaired selective response to PS using immunization with PPV23 and assessment of anti-PnPS IgG response by the serotype-specific WHO-standardized ELISA 4 to 8 weeks after immunization
Measured: 4 to 8 weeks after immunization
Secondary outcomes (6)
To describe infectious and non infectious associated diseases, including allergy and autoimmune diseases, in SPAD patients.
Measured: Througth study completion, an average 24 months
To assess the benefit of IgRT on the frequency of courses of antibiotic therapy.
Outcome measure: number of courses of antibiotics in the 12 months following IgRT start compared to the 12 months before IgRT
Measured: Througth study completion, an average 24 months
To assess the benefit of IgRT on QoL and daily life.
Outcome measure: number of missed work or school/university days in the 12 months following IgRT start compared to the 12 months before IgRT
Measured: Througth study completion, an average 24 months
To assess the benefit of prophylactic antibiotics on the frequency of courses of antibiotic therapy.
Outcome measure: frequency of courses of antibiotics in the 6 months following prophylaxis start compared to the 12 months before and/or number of patients switched to IgRT during the first 12 months.
Measured: Througth study completion, an average 24 months
To assess the benefit of prophylactic antibiotics on QoL and daily life.
Outcome measure: number of missed work or school/university days in the 12 months following prophylaxis start (or at the end of prophylactic antibiotics) compared to the 12 months before.
Measured: Througth study completion, an average 24 months
To collect serum and mononuclear cells for future research projects in SPAD and undiagnosed patients.
To collect serum and mononuclear cells for future research projects in SPAD and undiagnosed patients
Measured: Througth study completion, an average 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Mar 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific Antibody 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- French Healthcare network for rare immune and hematological disorders (MARIH), Takeda, VitalAire, Laboratoire français de Fractionnement et de Biotechnologies
- Responsible party
- Sponsor
- Investigators
- Guillaume LEFEVRE, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664035
- Sponsor's protocol ID
- 2021_0699
- Other IDs
- 2022-A00574-39
- Acronym
- DETECT
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Specific Polysaccharide Antibody Deficiency in Adult Patients With Unexplained Recurrent and/or Severe Bacterial Infections
- ClinicalTrials.gov ID
- NCT05664035
- Acronym / sponsor ID
- DETECT / 2021_0699
- Keywords
- Specific Antibody Deficiency, Predominant antibody deficiencies, Ig replacement therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- French Healthcare network for rare immune and hematological disorders (MARIH), Takeda, VitalAire, Laboratoire français de Fractionnement et de Biotechnologies
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Dec 2022 (actual)
- 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.
The DETECT study aims to demonstrate the importance of detecting SPAD in adult patients with recurrent benign and/or severe unexplained bacterial upper/lower respiratory tract infections. Unlike children in whom the deficit may be transient, long-term strategies are warranted in SPAD adult patients to prevent severe infections and lung disability. Beyond the diagnosis of this still unrecognized PID in adult patients, the investigators want to assess the impact of prophylactic antibiotics or IgRT on infections prevention and on quality of life in adult patients with the most severe clinical phenotypes, recurrent infections with high frequency of antibiotics take and/or recurrent infections with complications like bronchiectasis and/or severe infections requiring hospitalizations.
Detailed description
This multicenter observational prospective study will be conducted in 15 university or general hospitals, mostly centers included in the national network of the reference center CEREDIH. Pulmonologists, clinical immunologists and ENT specialists will be solicited in each center to refer patients for inclusions.
All patients who fulfill eligibility criteria will be tested for anti-pneumococcal polysaccharides (PnPSs) response with the 23-valent pneumococcal (unconjugated) vaccine (PPV23) (V1, Day 0: blood sample anti-PnPS antibodies, and immunization; V2, Day 28-56): blood sample for anti-PnPS antibodies).
If a SPAD would be diagnosed, the investigator will be free to consider prophylactic antibiotics and/or IgRT according to the medical history of the patient (notably in case of persistent infections while using prophylactic antibiotics). The efficiency on infections prevention and the impact on health-related quality of life (HRQoL) will be assessed 12 months after initiation of IgRT or prophylactic antibiotics (Visit 3).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Biological: Diagnosis of SPAD using immunization with PPV2318 to 65 year old patients with a history of recurrent bacterial infections of upper and/or lower respiratory tract for at least 2 years |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in Pneumology, Immunology, ENT or Infectious Diseases departments
Key inclusion criteria (5 listed)
- 18 to 65 year old patients
- With a history of recurrent bacterial infections of upper and/or lower respiratory tract for at least 2 years, and fulfilling the specific following criteria:
- Recurrent benign infections currently requiring 6 courses of antibiotics /year or more, or Bilateral bronchiectasis/bronchiolitis (after exclusion of cystic fibrosis and ciliary dyskinesia) AND recurrent benign infections currently requiring 3 courses of antibiotics /year or more or A history of severe upper/lower respiratory tract bacterial infection, and/or invasive infection with Streptococcus pneumonia, Streptococcus pyogenes or Haemophilus influenzae, which required hospitalization in the last 2 years, AND recurrent benign infections currently requiring 3 courses of antibiotics /year.
- Normal serum IgG, IgA, IgM and IgG subclasses levels, normal CH50 and serum complement C3 and C4 proteins levels, normal T cells count
- Normal B cell count, normal serum protein electrophoresis and immunofixation. (* excepted for Pseudomonas aeruginosa colonization)
Key exclusion criteria (5 listed)
- Any general condition that predisposes to infections: solid or hematological malignancies, 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;
- Any local predisposing factor to infections: cigarette smoking (> 10 pack-year and/or 5 cigarettes/day), underlying infection (tuberculosis, influenza…), chronic obstructive pulmonary disease, oral, dental or skin conditions favorizing infections, streptococcal skin infections
- Any other SID or PID diagnosed before inclusion
- Pregnancy
- PPV23 administration in the last 2 years (risk of hyporesponsiveness)
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 |
|---|---|---|
| Diagnosis of SPAD using immunization with PPV23Diagnosis of SPAD using immunization with PPV23 | Biological | Case group |
Primary outcome
To assess the frequency of SPAD in adult patients with unexplained recurrent bacterial respiratory infections
Time frame: 4 to 8 weeks after immunization
Diagnosis of SPAD according to the AAAAI proposed consensus criteria for an impaired selective response to PS using immunization with PPV23 and assessment of anti-PnPS IgG response by the serotype-specific WHO-standardized ELISA 4 to 8 weeks after immunization
6 secondary outcomes
To describe infectious and non infectious associated diseases, including allergy and autoimmune diseases, in SPAD patients.
Time frame: Througth study completion, an average 24 months
To assess the benefit of IgRT on the frequency of courses of antibiotic therapy.
Time frame: Througth study completion, an average 24 months
To assess the benefit of IgRT on QoL and daily life.
Time frame: Througth study completion, an average 24 months
To assess the benefit of prophylactic antibiotics on the frequency of courses of antibiotic therapy.
Time frame: Througth study completion, an average 24 months
To assess the benefit of prophylactic antibiotics on QoL and daily life.
Time frame: Througth study completion, an average 24 months
To collect serum and mononuclear cells for future research projects in SPAD and undiagnosed patients.
Time frame: Througth study completion, an average 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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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.
Guillaume LEFEVRE, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Specific Antibody Deficiency and Predominantly Antibody Deficiencies, run by University Hospital, Lille at 1 site 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume LEFEVRE, MD,PhD (0320445962 ext. +33, guillaume.lefevre@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the frequency of SPAD in adult patients with unexplained recurrent bacterial respiratory infections (time frame: 4 to 8 weeks after immunization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2026.