SPAD in Adult Patients (DETECT)

University Hospital, Lille

Status: Not yet enrolling

Conditions: Predominantly Antibody Deficiencies; Specific Antibody Deficiency

Treatments: Biological: Diagnosis of SPAD using immunization with PPV23

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05664035

2021_0699

2022-A00574-39 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

99 participants in 1 patient group

Case group

Description:

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

Treatment:

Biological: Diagnosis of SPAD using immunization with PPV23