Clinical trial NCT05664035: SPAD in Adult Patients
Official title: Detection of Specific Polysaccharide Antibody Deficiency in Adult Patients With Unexplained Recurrent and/or Severe Bacterial Infections
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Specific Antibody Deficiency
Predominantly Antibody Deficiencies
Keywords: Specific Antibody Deficiency
Predominant antibody deficiencies
Ig replacement therapy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: French Healthcare network for rare immune and hematological disorders (MARIH)
name: Takeda
name: VitalAire
name: Laboratoire français de Fractionnement et de Biotechnologies
First posted: 2022-12-23
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in Pneumology, Immunology, ENT or Infectious Diseases departments

Brief 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. 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, we 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: 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
timeFrame: to 8 weeks after immunization
Secondary outcomes:
measure: frequency of associated autoimmune or allergic diseases.
timeFrame: Througth study completion, an average 24 months
measure: number of courses of antibiotics in the 12 months following IgRT start compared to the 12 months before IgRT
timeFrame: Througth study completion, an average 24 months
measure: SF-36 questionnaire, number of missed work or school/university days in the 12 months following IgRT start compared to the 12 months before IgRT
timeFrame: Througth study completion, an average 24 months
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.
timeFrame: Througth study completion, an average 24 months
measure: SF-36 questionnaire, 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
timeFrame: Througth study completion, an average 24 months
measure: Biological collection
timeFrame: Througth study completion, an average 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Guillaume LEFEVRE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: