SPAD in Adult Patients

Specific Antibody Deficiency Clinical Trial

— DETECT  

Official title:

Detection of Specific Polysaccharide Antibody Deficiency in Adult Patients With Unexplained Recurrent and/or Severe Bacterial Infections

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05664035
• Other study ID #: 2021_0699
• Secondary ID: 2022-A00574-39
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: June 2026

Study information

• Verified date: December 2022
• Source: University Hospital, Lille
• Contact: Guillaume LEFEVRE, MD,PhD
• Phone: 0320445962
• Email: guillaume.lefevre[@]chu-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 99
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Specific Antibody Deficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Lille	French Healthcare network for rare immune and hematological disorders (MARIH), Laboratoire français de Fractionnement et de Biotechnologies, Takeda, VitalAire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	frequency of associated autoimmune or allergic diseases.		Througth study completion, an average 24 months
Secondary	number of courses of antibiotics in the 12 months following IgRT start compared to the 12 months before IgRT		Througth study completion, an average 24 months
Secondary	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		Througth study completion, an average 24 months
Secondary	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.		Througth study completion, an average 24 months
Secondary	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		Througth study completion, an average 24 months
Secondary	Biological collection	To collect serum and mononuclear cells for future research projects in SPAD and undiagnosed patients	Througth study completion, an average 24 months