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Recruiting Observational

Frequency of SPAD in Adult Patients

NCT05664035 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-03-01
Last updated
2026-05-18

Condition(s) studied

Specific Antibody DeficiencyPredominantly Antibody Deficiencies

Investigational drug(s) / intervention(s)

Diagnosis of SPAD using immunization with PPV23

Diagnosis of SPAD using immunization with PPV23: Diagnosis of SPAD using immunization with PPV23

Study 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, 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 outcome measure(s)

  • To assess the frequency of SPAD in adult patients with unexplained recurrent bacterial respiratory infections — 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

Trial sites (1)

FacilityCityRegionStatus
Lille University Hospital Lille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05664035 on ClinicalTrials.gov ↗ ← All trials in France