Detecting SPAD in adults with recurrent infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter observational study, adults aged 18–65 with recurrent upper or lower respiratory infections will be screened for Specific Antibody Deficiency using the PPV23 vaccine response. If SPAD is diagnosed, clinicians may use prophylactic antibiotics and/or immunoglobulin replacement therapy, and outcomes will be followed for 12 months to see effects on infections and health-related quality of life. The study involves 15 centers in France, with pulmonologists, clinical immunologists, and ENT specialists referring eligible patients. Anti-PnPS antibody responses will be measured at baseline and after vaccination to confirm SPAD. This design aims to describe the impact of SPAD management strategies in real-world adult settings.

Why it matters

Who can join: the full rules

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)

Where it's running

• Lille University Hospital
  Lille, France Recruiting

Study contacts

• Principal investigator: Guillaume LEFEVRE, MD,PhD — University Hospital, Lille
• Study coordinator: Guillaume LEFEVRE, MD,PhD
• Email: guillaume.lefevre@chu-lille.fr
• Phone: 0320445962

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.