SPAD in Adult Patients

Launched by UNIVERSITY HOSPITAL, LILLE · Dec 15, 2022

Keywords

ClinConnect Summary

The SPAD in Adult Patients trial is looking to understand a condition called Specific Antibody Deficiency (SPAD) in adults who frequently get bacterial infections in their lungs and airways. Many adults with this issue experience repeated infections that can lead to serious health problems, like lung damage. The study aims to see how effective preventive treatments, like antibiotics or immunoglobulin replacement therapy (IgRT), are at reducing these infections and improving the overall quality of life for patients.

To participate in this trial, individuals need to be between 18 and 65 years old and have a history of recurrent respiratory infections for at least two years, requiring multiple courses of antibiotics each year. Participants will undergo tests to ensure they meet specific health criteria, and they will be monitored to assess the impact of the treatments. It’s important to note that this trial is not yet recruiting participants, so interested individuals should stay tuned for updates on when they can join.

Gender

ALL

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)